A Phase 3 interventional study of Olodaterol (BI 1744) and Olodaterol (BI 1744) in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 93 sites in 20 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-06-27.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 906 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Low dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
High dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
12mcg inhaled twice daily from the Aerolizer inhaler
Drug: Formoterol
Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler
Drug: Placebo
Comparison of low and high doses on efficacy and safety in COPD patients
Comparison of low and high doses on efficacy and safety in COPD patients
Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients
Placebo for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients
Placebo for comparison Formoterolon safety and efficacy in COPD patients
Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24
Trough FEV1 Response at Week 24
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.
Mahler Transitional Dyspnea Index Focal Score at 24 Weeks
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Time frame: Baseline, Week 24
Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis
This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Time frame: Baseline, Week 24
Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks
Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).
Time frame: Baseline, Week 24
Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks
Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).
Time frame: Baseline, Week 12
Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks
Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).
Time frame: Baseline, Week 48
Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis
Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.
Time frame: Baseline, Week 24
Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2
Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6
Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12
Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48
Trough FEV1 Response at Week 2
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.
Trough FEV1 Response at Week 6
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.
Trough FEV1 Response at Week 12
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.
Trough FEV1 Response at Week 18
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.
Trough FEV1 Response at Week 32
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.
Trough FEV1 Response at Week 40
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.
Trough FEV1 Response at Week 48
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.
Peak FEV1 (0-3h) Response After 2 Weeks
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks
Peak FEV1 (0-3h) Response After 6 Weeks
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks
Peak FEV1 (0-3h) Response After 12 Weeks
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks
Peak FEV1 (0-3h) Response After 24 Weeks
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks
Peak FEV1 (0-3h) Response After 48 Weeks
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24
Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48
Trough FVC Response at Week 2
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.
Trough FVC Response at Week 6
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.
Trough FVC Response at Week 12
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.
Trough FVC Response at Week 18
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.
Trough FVC Response at Week 24
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.
Trough FVC Response at Week 32
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.
Trough FVC Response at Week 48
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.
Trough FVC Response at Week 40
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.
Peak FVC (0-3h) Response After 2 Weeks
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks
Peak FVC (0-3h) Response After 6 Weeks
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks
Peak FVC (0-3h) Response After 12 Weeks
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks
Peak FVC (0-3h) Response After 24 Weeks
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks
Peak FVC (0-3h) Response After 48 Weeks
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
Time frame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks
Peak Expiratory Flow Rate (PEFR) at Week 24
Weekly mean pre-dose morning and evening PEFR. Results are from non-MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.
Time frame: Week 24
Use of Rescue Medication at Week 24
Mean number of puffs of rescue medication used per day (daytime/nighttime/total)
Time frame: Week 24
Patient's Global Rating (PGR) at 6 Weeks
Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
Time frame: Week 6
Patient's Global Rating (PGR) at 12 Weeks
Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
Time frame: Week 12
Patient's Global Rating (PGR) at 24 Weeks
Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
Time frame: Week 24
Patient's Global Rating (PGR) at 48 Weeks
Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
Time frame: Week 48
Mahler Transitional Dyspnea Index Focal Score at 6 Weeks
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Time frame: Baseline, Week 6
Mahler Transitional Dyspnea Index Focal Score at 12 Weeks
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Time frame: Baseline, Week 12
Mahler Transitional Dyspnea Index Focal Score at 18 Weeks
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Time frame: Baseline, Week 18
Mahler Transitional Dyspnea Index Focal Score at 32 Weeks
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Time frame: Baseline, Week 32
Mahler Transitional Dyspnea Index Focal Score at 40 Weeks
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Time frame: Baseline, Week 40
Mahler Transitional Dyspnea Index Focal Score at 48 Weeks
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
Time frame: Baseline, Week 48
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.
Time frame: Baseline to end of study at 48 weeks.
Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.
Time frame: Baseline to end of study at 48 weeks.
Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.
Time frame: Baseline to end of study at 48 weeks.
Number of COPD Exacerbations
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.
Time frame: Baseline to end of study at week 48 visit
Number of COPD Exacerbations Requiring Hospitalization
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.
Time frame: Baseline to end of study at week 48 visit
Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.
Time frame: Baseline to end of study at 48 weeks.
Absolute Plasma Concentrations
Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.
Time frame: within 2 hours before first drug administration and 10 minutes post-dose at week 6, 12 and 18
Changes in Safety Parameters Related to Treatment
Occurence of cardiac disorders and investigations related to treatment.
Time frame: 48 weeks
| Milestone | Placebo | Olodaterol (Olo) 5 mcg qd | Olodaterol (Olo) 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Started | 225 | 227 | 225 | 227 |
| Completed | 168 | 191 | 186 | 184 |
| Not completed | 57 | 36 | 39 | 43 |
| Withdrew: Adverse event | 18 | 16 | 15 | 20 |
| Withdrew: Lost to follow-up | 2 | 2 | 4 | 0 |
| Withdrew: Withdrawal by subject | 20 | 9 | 11 | 14 |
| Withdrew: Lack of efficacy | 9 | 2 | 1 | 3 |
| Withdrew: Non compliance with protocol | 2 | 3 | 2 | 3 |
| Withdrew: Other reason not described above | 6 | 4 | 6 | 3 |
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks | -0.009 ± 0.016 | 0.142 ± 0.015 | 0.156 ± 0.015 | 0.168 ± 0.015 |
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FEV1 Response at Week 24 | -0.056 ± 0.015 | 0.021 ± 0.015 | 0.028 ± 0.015 | -0.002 ± 0.015 |
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Mahler Transitional Dyspnea Index Focal Score at 24 Weeks | 2.046 ± 0.255 | 2.234 ± 0.240 | 2.068 ± 0.245 | 1.818 ± 0.247 |
Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks | 41.068 ± 1.038 | 38.627 ± 0.995 | 37.674 ± 0.998 | 40.116 ± 0.994 |
Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks | 42.105 ± 1.027 | 39.320 ± 0.986 | 36.961 ± 0.989 | 40.351 ± 0.992 |
Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks | 40.415 ± 1.057 | 38.545 ± 1.000 | 36.850 ± 1.015 | 40.431 ± 1.015 |
Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis | 41.639 ± 0.718 | 38.794 ± 0.693 | 38.205 ± 0.695 | 40.391 ± 0.699 |
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks | 0.015 ± 0.015 | 0.201 ± 0.015 | 0.181 ± 0.015 | 0.221 ± 0.015 |
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks | 0.001 ± 0.015 | 0.178 ± 0.015 | 0.161 ± 0.015 | 0.194 ± 0.015 |
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks | -0.003 ± 0.015 | 0.176 ± 0.015 | 0.167 ± 0.015 | 0.182 ± 0.015 |
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks | -0.023 ± 0.016 | 0.122 ± 0.015 | 0.123 ± 0.015 | 0.149 ± 0.015 |
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FEV1 Response at Week 2 | -0.019 ± 0.015 | 0.068 ± 0.014 | 0.060 ± 0.014 | 0.061 ± 0.014 |
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FEV1 Response at Week 6 | -0.037 ± 0.015 | 0.049 ± 0.014 | 0.041 ± 0.014 | 0.042 ± 0.014 |
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FEV1 Response at Week 12 | -0.027 ± 0.015 | 0.056 ± 0.014 | 0.048 ± 0.014 | 0.033 ± 0.015 |
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FEV1 Response at Week 18 | -0.019 ± 0.015 | 0.046 ± 0.014 | 0.026 ± 0.015 | 0.023 ± 0.015 |
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FEV1 Response at Week 32 | -0.023 ± 0.015 | 0.023 ± 0.015 | 0.026 ± 0.015 | 0.021 ± 0.015 |
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FEV1 Response at Week 40 | -0.020 ± 0.016 | 0.020 ± 0.015 | 0.017 ± 0.015 | 0.004 ± 0.015 |
Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FEV1 Response at Week 48 | -0.065 ± 0.015 | 0.003 ± 0.015 | -0.009 ± 0.015 | -0.006 ± 0.015 |
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FEV1 (0-3h) Response After 2 Weeks | 0.100 ± 0.016 | 0.277 ± 0.016 | 0.250 ± 0.016 | 0.290 ± 0.016 |
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FEV1 (0-3h) Response After 6 Weeks | 0.081 ± 0.016 | 0.248 ± 0.016 | 0.234 ± 0.016 | 0.264 ± 0.016 |
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FEV1 (0-3h) Response After 12 Weeks | 0.082 ± 0.016 | 0.247 ± 0.016 | 0.241 ± 0.016 | 0.256 ± 0.016 |
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FEV1 (0-3h) Response After 24 Weeks | 0.068 ± 0.017 | 0.216 ± 0.016 | 0.225 ± 0.016 | 0.236 ± 0.016 |
Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FEV1 (0-3h) Response After 48 Weeks | 0.053 ± 0.017 | 0.192 ± 0.016 | 0.193 ± 0.016 | 0.215 ± 0.016 |
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks | 0.076 ± 0.028 | 0.299 ± 0.027 | 0.311 ± 0.027 | 0.383 ± 0.027 |
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks | 0.016 ± 0.028 | 0.252 ± 0.027 | 0.265 ± 0.027 | 0.326 ± 0.027 |
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks | 0.023 ± 0.028 | 0.233 ± 0.027 | 0.278 ± 0.027 | 0.300 ± 0.028 |
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks | 0.037 ± 0.029 | 0.220 ± 0.027 | 0.252 ± 0.028 | 0.279 ± 0.028 |
Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks | 0.016 ± 0.029 | 0.196 ± 0.028 | 0.219 ± 0.028 | 0.260 ± 0.028 |
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FVC Response at Week 2 | 0.042 ± 0.028 | 0.110 ± 0.027 | 0.119 ± 0.028 | 0.126 ± 0.028 |
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FVC Response at Week 6 | -0.046 ± 0.029 | 0.065 ± 0.027 | 0.085 ± 0.028 | 0.090 ± 0.028 |
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FVC Response at Week 12 | -0.018 ± 0.029 | 0.079 ± 0.028 | 0.087 ± 0.028 | 0.068 ± 0.028 |
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FVC Response at Week 18 | 0.060 ± 0.029 | 0.066 ± 0.028 | 0.078 ± 0.028 | 0.063 ± 0.028 |
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FVC Response at Week 24 | -0.018 ± 0.029 | 0.038 ± 0.028 | 0.064 ± 0.028 | 0.001 ± 0.029 |
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FVC Response at Week 32 | 0.019 ± 0.030 | 0.080 ± 0.028 | 0.084 ± 0.028 | 0.077 ± 0.029 |
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FVC Response at Week 48 | -0.061 ± 0.030 | 0.022 ± 0.028 | -0.002 ± 0.029 | 0.006 ± 0.029 |
Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Trough FVC Response at Week 40 | 0.028 ± 0.030 | 0.087 ± 0.028 | 0.086 ± 0.028 | 0.052 ± 0.029 |
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FVC (0-3h) Response After 2 Weeks | 0.268 ± 0.029 | 0.454 ± 0.028 | 0.474 ± 0.028 | 0.551 ± 0.029 |
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FVC (0-3h) Response After 6 Weeks | 0.202 ± 0.029 | 0.411 ± 0.028 | 0.433 ± 0.029 | 0.467 ± 0.029 |
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FVC (0-3h) Response After 12 Weeks | 0.194 ± 0.030 | 0.382 ± 0.029 | 0.432 ± 0.029 | 0.450 ± 0.029 |
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FVC (0-3h) Response After 24 Weeks | 0.207 ± 0.030 | 0.379 ± 0.029 | 0.414 ± 0.029 | 0.424 ± 0.029 |
Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Peak FVC (0-3h) Response After 48 Weeks | 0.193 ± 0.031 | 0.344 ± 0.029 | 0.371 ± 0.030 | 0.416 ± 0.030 |
Weekly mean pre-dose morning and evening PEFR. Results are from non-MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.
| L/min | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| morning PEFR (N=214, 212, 216, 218) | 196.429 ± 3.392 | 211.496 ± 3.420 | 211.428 ± 3.379 | 214.070 ± 3.373 |
| evening PEFR (N=215, 211, 215, 221) | 202.256 ± 3.363 | 219.977 ± 3.408 | 220.727 ± 3.360 | 220.129 ± 3.332 |
Mean number of puffs of rescue medication used per day (daytime/nighttime/total)
| Number of puffs | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Daytime | 1.364 ± 0.097 | 0.961 ± 0.099 | 1.037 ± 0.097 | 1.217 ± 0.097 |
| Nighttime | 2.051 ± 0.125 | 1.449 ± 0.126 | 1.471 ± 0.125 | 1.701 ± 0.124 |
| Total | 3.390 ± 0.196 | 2.399 ± 0.198 | 2.488 ± 0.196 | 2.917 ± 0.195 |
Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Patient's Global Rating (PGR) at 6 Weeks | 3.4 ± 0.1 | 3.0 ± 0.1 | 3.1 ± 0.1 | 3.1 ± 0.1 |
Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Patient's Global Rating (PGR) at 12 Weeks | 3.3 ± 0.1 | 3.0 ± 0.1 | 2.9 ± 0.1 | 3.0 ± 0.1 |
Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Patient's Global Rating (PGR) at 24 Weeks | 3.1 ± 0.1 | 2.9 ± 0.1 | 2.9 ± 0.1 | 3.0 ± 0.1 |
Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Patient's Global Rating (PGR) at 48 Weeks | 3.1 ± 0.1 | 3.0 ± 0.1 | 2.9 ± 0.1 | 2.9 ± 0.1 |
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Mahler Transitional Dyspnea Index Focal Score at 6 Weeks | 0.995 ± 0.248 | 1.566 ± 0.236 | 1.660 ± 0.240 | 1.753 ± 0.243 |
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Mahler Transitional Dyspnea Index Focal Score at 12 Weeks | 1.412 ± 0.252 | 1.792 ± 0.239 | 1.955 ± 0.242 | 1.805 ± 0.245 |
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Mahler Transitional Dyspnea Index Focal Score at 18 Weeks | 1.665 ± 0.254 | 1.897 ± 0.240 | 2.099 ± 0.244 | 1.689 ± 0.246 |
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Mahler Transitional Dyspnea Index Focal Score at 32 Weeks | 1.732 ± 0.257 | 1.898 ± 0.241 | 1.698 ± 0.247 | 1.966 ± 0.249 |
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Mahler Transitional Dyspnea Index Focal Score at 40 Weeks | 1.952 ± 0.259 | 1.839 ± 0.241 | 1.887 ± 0.249 | 1.575 ± 0.251 |
Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Mahler Transitional Dyspnea Index Focal Score at 48 Weeks | 1.940 ± 0.259 | 2.035 ± 0.242 | 2.324 ± 0.250 | 2.047 ± 0.251 |
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.
| Days | Placebo (Tiotropium) | Placebo (Non-tiotropium) | Olo 5 mcg qd (Tiotropium) | Olo 5 mcg qd (Non-tiotropium) | Olo 10 mcg qd (Tiotropium) | Olo 10 mcg qd(Non-tiotropium) | Form 12 mcg (Tiotropium) | Form 12 mcg (Non-tiotropium) |
|---|---|---|---|---|---|---|---|---|
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 143 (70.0 to 254.0) | 268 (149.0 to NA) | 136 (74.0 to 255.0) | 189 (115.0 to 262.0) | 134 (61.0 to 200.0) | 209 (109.0 to 290.0) | 223 (115.0 to 280.0) | 310 (207.0 to NA) |
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.
| Days | Placebo (Tiotropium) | Placebo (Non-tiotropium) | Olo 5 mcg qd (Tiotropium) | Olo 5 mcg qd (Non-tiotropium) | Olo 10 mcg qd (Tiotropium) | Olo 10 mcg qd(Non-tiotropium) | Form 12 mcg (Tiotropium) | Form 12 mcg (Non-tiotropium) |
|---|---|---|---|---|---|---|---|---|
| Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.
| Days | Placebo (Tiotropium) | Placebo (Non-tiotropium) | Olo 5 mcg qd (Tiotropium) | Olo 5 mcg qd (Non-tiotropium) | Olo 10 mcg qd (Tiotropium) | Olo 10 mcg qd(Non-tiotropium) | Form 12 mcg (Tiotropium) | Form 12 mcg (Non-tiotropium) |
|---|---|---|---|---|---|---|---|---|
| Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation | 150 (86.0 to 325.0) | 296 (215.0 to NA) | 239 (98.0 to 304.0) | 244 (154.0 to NA) | 175 (123.0 to 271.0) | 302 (213.0 to NA) | 280 (167.0 to NA) | 270 (270.0 to NA) |
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.
| Number of COPD ex. per patient year | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Number of COPD Exacerbations | 0.5684 ± 0.0718 | 0.7117 ± 0.0793 | 0.6946 ± 0.0801 | 0.5098 ± 0.0649 |
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.
| Number of COPD ex. per patient year | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Number of COPD Exacerbations Requiring Hospitalization | 0.0554 ± 0.0249 | 0.1043 ± 0.0378 | 0.1324 ± 0.0493 | 0.0570 ± 0.0227 |
Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.
| Number of COPD ex. per patient year | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations | 0.4765 ± 0.0645 | 0.5537 ± 0.0674 | 0.5114 ± 0.0654 | 0.3721 ± 0.0537 |
Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.
| pg/mL | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Absolute Plasma Concentrations | — | 4.179 ± 60.300 | 7.246 ± 72.242 | — |
Occurence of cardiac disorders and investigations related to treatment.
| percentage of participants | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Tachycardia | 0.4 | 0.0 | 0.0 | 0.9 |
| Arrhythmia | 0.0 | 0.4 | 0.0 | 0.0 |
| Atrial fibrillation | 0.4 | 0.0 | 0.0 | 0.4 |
| Atrioventricular block | 0.4 | 0.0 | 0.0 | 0.0 |
| Atrioventricular block first degree | 0.0 | 0.0 | 0.0 | 0.4 |
| Bundle branch block right | 0.0 | 0.4 | 0.0 | 0.0 |
| Palpitations | 0.4 | 0.0 | 0.0 | 0.4 |
| Ventricular extrasystoles | 0.4 | 0.0 | 0.0 | 0.0 |
| Electrocardiogram QT prolonged | 0.0 | 0.4 | 0.0 | 0.4 |
| Electrocardiogram T wave inversion | 0.0 | 0.0 | 0.0 | 0.4 |
This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).
| score on a scale | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis | 1.471 ± 0.155 | 1.980 ± 0.175 | 1.996 ± 0.170 | 1.827 ± 0.168 |
Collected over 48 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 31/225 (13.8%) | 83/225 (36.9%) |
| Olodaterol (Olo) 5 mcg qd | — | 33/227 (14.5%) | 100/227 (44.1%) |
| Olodaterol (Olo) 10 mcg qd | — | 26/225 (11.6%) | 96/225 (42.7%) |
| Form 12 mcg | — | 33/227 (14.5%) | 83/227 (36.6%) |
| Event | Placebo | Olodaterol (Olo) 5 mcg qd | Olodaterol (Olo) 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 9/225 | 10/227 | 13/225 | 9/227 |
| PneumoniaInfections and infestations | 3/225 | 6/227 | 8/225 | 3/227 |
| Atrial fibrillationCardiac disorders | 0/225 | 1/227 | 3/225 | 1/227 |
| GastroenteritisInfections and infestations | 3/225 | 1/227 | 0/225 | 0/227 |
| Infective exacerbation of chronic obstructive airways diseaseInfections and infestations | 2/225 | 0/227 | 1/225 | 1/227 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/225 | 0/227 | 0/225 | 0/227 |
| AnaemiaBlood and lymphatic system disorders | 1/225 | 1/227 | 0/225 | 0/227 |
| Acute coronary syndromeCardiac disorders | 1/225 | 0/227 | 0/225 | 0/227 |
| Acute myocardial infarctionCardiac disorders | 1/225 | 1/227 | 0/225 | 0/227 |
| Cardiac failureCardiac disorders | 0/225 | 0/227 | 1/225 | 1/227 |
| Event | Placebo | Olodaterol (Olo) 5 mcg qd | Olodaterol (Olo) 10 mcg qd | Form 12 mcg |
|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 51/225 | 67/227 | 62/225 | 53/227 |
| NasopharyngitisInfections and infestations | 15/225 | 22/227 | 25/225 | 23/227 |
| Upper respiratory tract infectionInfections and infestations | 15/225 | 17/227 | 11/225 | 11/227 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/225 | 7/227 | 13/225 | 13/227 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 11/225 | 9/227 | 13/225 | 6/227 |
| Age, Continuous(years) | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg | Total |
|---|---|---|---|---|---|
| Mean | 64.0 ± 8.4 | 63.7 ± 9.1 | 62.6 ± 8.8 | 64.8 ± 8.6 | 63.8 ± 8.7 |
| Sex: Female, Male(Participants) | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg | Total |
|---|---|---|---|---|---|
| Female | 45 | 50 | 55 | 48 | 198 |
| Male | 180 | 177 | 170 | 179 | 706 |
| Tiotropium (Tio) Use Stratum(Number of participants) | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Form 12 mcg | Total |
|---|---|---|---|---|---|
| Non-tiotropium | 169 | 168 | 167 | 169 | 673 |
| Tiotropium | 56 | 59 | 58 | 58 | 231 |
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Boehringer Ingelheim