A Phase 3 interventional study of Olodaterol (BI1744) Low and Olodaterol (BI1744) High in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 12 sites in 4 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-06-30.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (COPD) patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 122 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 Respimat inhaler
Drug: Olodaterol (BI1744) Low
High dose inhaled orally once daily from Respimat inhaler
Drug: Olodaterol (BI1744) High
18 mcg inhaled once daily from HandiHaler
Drug: Tiotropium 18 mcg
Olodaterol placebo and/or Tiotropium placebo inhaled once daily
Drug: Placebo (for Olodaterol (BI1744)l) · Drug: Placebo (for Tiotropium)
Low dose inhaled orally once daily from Respimat inhaler
High dose inhaled orally once daily from Respimat inhaler
18 mcg inhaled once daily from HandiHaler
Placebo (olodaterol low and high dose) delivered by Respimat
Placebo (Tiotropium 18 mcg) delivered by HandiHaler
FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment
FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
Time frame: 1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose at the first randomized treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the treatment at the first treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.
Time frame: 1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.
Time frame: 1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment after six weeks of treatment
Peak FEV1 (0-3h) Response
Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
Time frame: Study baseline and first day of dosing
Peak FEV1 (0-3h) Response
Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
Time frame: Study baseline and 6 weeks
Trough FEV1 Response
Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment for the first period. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
Time frame: Study baseline and 6 weeks
Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.
FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Time frame: 1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment
FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment
FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment
FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
Time frame: 1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose of treatment after six weeks of treatment
Peak FVC (0-3h) Response
Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment for the first period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
Time frame: Study baseline and 6 weeks
Trough FVC Response
Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment for the first period. Trough values were the mean of obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
Time frame: Study baseline and 6 weeks
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).
Time frame: 6 weeks
| Milestone | Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg | Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo | Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg | Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg |
|---|---|---|---|---|
| Started | 31 | 30 | 31 | 30 |
| Completed | 27 | 19 | 30 | 24 |
| Not completed | 4 | 11 | 1 | 6 |
| Withdrew: Adverse event | 4 | 8 | 0 | 4 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 | 1 |
| Withdrew: Other reasons not listed above | 0 | 1 | 0 | 0 |
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment | -0.008 ± 0.019 | 0.189 ± 0.019 | 0.213 ± 0.019 | 0.213 ± 0.019 |
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment | -0.059 ± 0.018 | 0.094 ± 0.018 | 0.111 ± 0.018 | 0.105 ± 0.018 |
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose at the first randomized treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment | -0.033 ± 0.019 | 0.142 ± 0.018 | 0.158 ± 0.018 | 0.159 ± 0.018 |
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the treatment at the first treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment | 0.018 ± 0.018 | 0.232 ± 0.017 | 0.256 ± 0.017 | 0.169 ± 0.018 |
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment | 0.011 ± 0.020 | 0.225 ± 0.019 | 0.255 ± 0.020 | 0.246 ± 0.019 |
Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| Peak FEV1 (0-3h) Response | 0.076 ± 0.019 | 0.313 ± 0.019 | 0.342 ± 0.019 | 0.251 ± 0.019 |
Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| Peak FEV1 (0-3h) Response | 0.082 ± 0.020 | 0.290 ± 0.020 | 0.325 ± 0.020 | 0.325 ± 0.020 |
Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment for the first period. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| Trough FEV1 Response | 0.003 ± 0.019 | 0.137 ± 0.019 | 0.146 ± 0.019 | 0.161 ± 0.019 |
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response | -0.006 ± 0.035 | 0.324 ± 0.034 | 0.321 ± 0.035 | 0.364 ± 0.035 |
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response | -0.109 ± 0.036 | 0.169 ± 0.035 | 0.155 ± 0.036 | 0.192 ± 0.035 |
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response | -0.057 ± 0.036 | 0.247 ± 0.035 | 0.226 ± 0.036 | 0.278 ± 0.035 |
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response | 0.053 ± 0.035 | 0.423 ± 0.034 | 0.419 ± 0.034 | 0.316 ± 0.034 |
Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response | 0.044 ± 0.035 | 0.388 ± 0.034 | 0.397 ± 0.035 | 0.414 ± 0.034 |
Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment for the first period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| Peak FVC (0-3h) Response | 0.191 ± 0.037 | 0.526 ± 0.036 | 0.537 ± 0.037 | 0.569 ± 0.037 |
Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment for the first period. Trough values were the mean of obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.
| Liter | Placebo | Olo 5 mcg qd | Olo 10 mcg qd | Tio 18 mcg qd |
|---|---|---|---|---|
| Trough FVC Response | -0.001 ± 0.037 | 0.243 ± 0.036 | 0.215 ± 0.037 | 0.255 ± 0.037 |
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).
| participants | Placebo | Olo 5 mcg | Olo 10 mcg | Tiotropium (Tio) 18 mcg qd |
|---|---|---|---|---|
| Potassium increased | 1 | 0 | 0 | 0 |
| Atrial fibrillation | 0 | 0 | 1 | 0 |
| Palpitations | 0 | 0 | 1 | 0 |
Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 5/109 (4.6%) | 8/109 (7.3%) |
| Olo 5 mcg | — | 3/115 (2.6%) | 14/115 (12.2%) |
| Olo 10 mcg | — | 8/113 (7.1%) | 6/113 (5.3%) |
| Tiotropium (Tio) 18 mcg qd | — | 2/113 (1.8%) | 4/113 (3.5%) |
| Event | Placebo | Olo 5 mcg | Olo 10 mcg | Tiotropium (Tio) 18 mcg qd |
|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/109 | 0/115 | 4/113 | 1/113 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 1/109 | 0/115 | 0/113 | 0/113 |
| Cellulitis staphylococcalInfections and infestations | 1/109 | 0/115 | 0/113 | 0/113 |
| Fracture displacementInjury, poisoning and procedural complications | 1/109 | 0/115 | 0/113 | 0/113 |
| Atrial fibrillationCardiac disorders | 0/109 | 0/115 | 1/113 | 0/113 |
| Retinal detachmentEye disorders | 0/109 | 0/115 | 1/113 | 0/113 |
| PneumoniaInfections and infestations | 0/109 | 0/115 | 1/113 | 0/113 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/109 | 0/115 | 0/113 | 1/113 |
| Neuroendocrine carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/109 | 0/115 | 1/113 | 0/113 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 0/109 | 0/115 | 1/113 | 0/113 |
| Event | Placebo | Olo 5 mcg | Olo 10 mcg | Tiotropium (Tio) 18 mcg qd |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 4/109 | 8/115 | 4/113 | 4/113 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 4/109 | 6/115 | 3/113 | 1/113 |
| Age, Continuous(years) | Study Total |
|---|---|
| Mean | 62.7 ± 7.9 |
| Sex: Female, Male(Participants) | Study Total |
|---|---|
| Female | 47 |
| Male | 75 |
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Boehringer Ingelheim