A Phase 3 interventional study of Glycopyrronium bromide and Placebo to glycopyrronium bromide in Chronic Obstructive Pulmonary Disease, sponsored by Novartis. Completed at 139 sites in 16 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-08-17.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 1,066 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply to the study.
Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Glycopyrronium bromide
Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Placebo to glycopyrronium bromide
Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Tiotropium
Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Also known as: NVA237
Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.
Time frame: Week 12
Transition Dyspnea Index (TDI) at Week 26
The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure.
Time frame: Week 26
Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52
The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure.
Time frame: Week 52
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)
Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.
Time frame: Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks)
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52)
The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The mean daily number of puffs of rescue medication taken was calculated by dividing the number of puffs of rescue medication per day over the 52 weeks of the study by the number of days with non-missing rescue medication data. Rescue medication data recorded during the 14 day run-in period was used to calculate the baseline. The analysis included the same covariates as the primary Outcome Measure. A positive change score indicates more puffs taken.
Time frame: Baseline to Week 52
Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included the same covariates as the primary Outcome Measure.
Time frame: Day 1, Week 26, and Week 52
Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52
Trough FVC is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FVC values. Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told "At the end of the next normal breath out, take a deep breath all the way in"; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure.
Time frame: Day 1, Week 12, Week 26, and Week 52
Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
Time frame: 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told "At the end of the next normal breath out, take a deep breath all the way in"; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
Time frame: 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
Time frame: 5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told "At the end of the next normal breath out, take a deep breath all the way in"; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
Time frame: 5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, and 4 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.
Time frame: From 5 minutes to 4 hours post-dose at Day 1 and Weeks 12, 26, and 52
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, 4, 6, 8 10, and 12 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.
Time frame: From 5 minutes to 12 hours post-dose at Day 1 and Weeks 12 and 52
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.
Time frame: From 5 minutes to 23 hours 45 minutes post-dose at Weeks 12 and 52
Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52)
The number of moderate or severe exacerbations of COPD per year during the study was calculated by dividing the total number of exacerbations during the study by the total number of years of treatment. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.
Time frame: Baseline to Week 52
Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)
A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.
Time frame: Baseline to Week 52
Percentage of Nights With "no Nighttime Awakenings" During the Study (Baseline to Week 52)
A night with "no nighttime awakenings" was defined as any night where the patient did not wake up due to 1 or more of 6 symptoms (respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Symptoms occurring during the previous 12 hours were recorded each morning and evening by the patient in an electronic diary. The percentage of nights with 'no nighttime awakenings' was calculated as the total number of nights with "no nighttime awakenings" over the 52 week treatment period divided by the total number of nights where diary recordings were made.
Time frame: Baseline to Week 52
Percentage of Days With "no Daytime Symptoms" During the Study (Baseline to Week 52)
A day with "no daytime symptoms" was defined as any day where the patient recorded no cough, no wheeze, no production of sputum, no feeling of breathlessness (other than when running), and no puffs of rescue medication during the previous 12 hours in evening entry in the electronic patient diary. The percentage of days with "no daytime symptoms" was calculated as the total number of days with "no daytime symptoms" over the 52 week treatment period divided by the total number of days where diary recordings were made.
Time frame: Baseline to Week 52
Percentage of "Days Able to Perform Usual Daily Activities" During the Study (Baseline to Week 52)
A "day able to perform usual daily activities" was defined as any day where the patient recorded in their electronic diary in the evening that they were not prevented from performing their usual daily activities due to respiratory symptoms during the previous 12 hours. The percentage of "days able to perform usual daily activities" was calculated as the total number of "days able to perform usual daily activities" over the 52 week treatment period divided by the total number of days where diary recordings were made.
Time frame: Baseline to Week 52
Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52)
The daily total symptom score was defined as the sum of the morning and evening patient self-reported diary assessments of 6 symptoms (respiratory symptoms/impact on daily activities, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Means for baseline (14 day maximum run-in period) and the 52 week treatment period were calculated. Mean scores ranged from 0-18, with a higher score indicating worse symptoms. A negative change score indicated improvement.
Time frame: Baseline to Week 52
A total of 1993 patients were screened from 180 participating sites, of whom 1066 were randomized to 1 of the 3 treatment groups in a 2:1:1 ratio glycopyrronium bromide:placebo:tiotropium.
| Milestone | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Started | 529 | 269 | 268 |
| Completed | 411 | 193 | 206 |
| Not completed | 118 | 76 | 62 |
| Withdrew: Adverse event | 40 | 29 | 18 |
| Withdrew: Subject withdrew consent | 40 | 23 | 26 |
| Withdrew: Unsatisfactory therapeutic effect | 20 | 9 | 6 |
| Withdrew: Lost to follow-up | 7 | 7 | 3 |
| Withdrew: Protocol deviation | 5 | 2 | 4 |
| Withdrew: Administrative problems | 4 | 1 | 2 |
| Withdrew: Death | 2 | 2 | 2 |
| Withdrew: Abnormal laboratory value(s) | 0 | 1 | 0 |
| Withdrew: Abnormal test procedure result(s) | 0 | 1 | 1 |
| Withdrew: Patient inability to use the device | 0 | 1 | 0 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | 1.469 ± 0.0141 | 1.372 ± 0.0173 | 1.455 ± 0.0170 |
The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure.
| Units on a scale | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Transition Dyspnea Index (TDI) at Week 26 | 2.13 ± 0.240 | 1.32 ± 0.289 | 2.26 ± 0.281 |
The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure.
| Units on a scale | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52 | 40.85 ± 0.854 | 44.16 ± 1.040 | 41.32 ± 1.024 |
Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.
| Days | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | 363.0 (1 to 402) | 231.0 (1 to 380) | 364.0 (1 to 423) |
The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The mean daily number of puffs of rescue medication taken was calculated by dividing the number of puffs of rescue medication per day over the 52 weeks of the study by the number of days with non-missing rescue medication data. Rescue medication data recorded during the 14 day run-in period was used to calculate the baseline. The analysis included the same covariates as the primary Outcome Measure. A positive change score indicates more puffs taken.
| Puffs | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52) | -1.58 ± 0.151 | -1.20 ± 0.184 | -1.83 ± 0.183 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included the same covariates as the primary Outcome Measure.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Day 1 | 1.478 ± 0.0088 | 1.388 ± 0.0109 | 1.471 ± 0.0109 |
| Week 26 (n=451, 219, 233) | 1.458 ± 0.0161 | 1.324 ± 0.0196 | 1.408 ± 0.0191 |
| Week 52 (n=416, 196, 210) | 1.412 ± 0.0157 | 1.303 ± 0.0198 | 1.392 ± 0.0191 |
Trough FVC is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FVC values. Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told "At the end of the next normal breath out, take a deep breath all the way in"; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Day 1 | 2.936 ± 0.0165 | 2.757 ± 0.0205 | 2.930 ± 0.0206 |
| Week 12 (n=442, 204, 217) | 2.985 ± 0.0265 | 2.802 ± 0.0329 | 2.970 ± 0.0323 |
| Week 26 (n=418, 196, 208) | 2.962 ± 0.0299 | 2.758 ± 0.0361 | 2.892 ± 0.0355 |
| Week 52 (n=395, 186, 201) | 2.866 ± 0.0335 | 2.687 ± 0.0399 | 2.866 ± 0.0383 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Day 1, minute 5 (n=135, 74, 74) | 1.494 ± 0.0135 | 1.416 ± 0.0166 | 1.447 ± 0.0164 |
| Day 1, minute 15 (n=139, 75, 74) | 1.548 ± 0.0152 | 1.428 ± 0.0185 | 1.485 ± 0.0185 |
| Day 1, minute 30 (n=143, 77, 74) | 1.561 ± 0.0180 | 1.409 ± 0.0218 | 1.483 ± 0.0219 |
| Day 1, hour 1 (n=144, 76, 75) | 1.583 ± 0.0172 | 1.404 ± 0.0213 | 1.514 ± 0.0212 |
| Day 1, hour 2 (n=144, 75, 75) | 1.639 ± 0.0202 | 1.445 ± 0.0248 | 1.569 ± 0.0247 |
| Day 1, hour 3 (n=143, 74, 73) | 1.629 ± 0.0199 | 1.435 ± 0.0249 | 1.587 ± 0.0248 |
| Day 1, hour 4 (n=144, 70, 74) | 1.599 ± 0.0221 | 1.415 ± 0.0281 | 1.560 ± 0.0275 |
| Day 1, hour 6 (n=142, 71, 74) | 1.578 ± 0.0204 | 1.426 ± 0.0255 | 1.575 ± 0.0252 |
| Day 1, hour 8 (n=137, 70, 75) | 1.544 ± 0.0226 | 1.431 ± 0.0284 | 1.545 ± 0.0278 |
| Day1, hour 10 (n=134, 72, 75) | 1.546 ± 0.0235 | 1.415 ± 0.0290 | 1.537 ± 0.0286 |
| Day 1, hour 12 (n=130, 69, 70) | 1.522 ± 0.0254 | 1.369 ± 0.0307 | 1.480 ± 0.0306 |
| Day 1, hour 23, minute 15 (n=129, 71, 72) | 1.471 ± 0.0214 | 1.396 ± 0.0259 | 1.481 ± 0.0255 |
| Day 1, hour 23, minute 45 (n=128, 74, 75) | 1.518 ± 0.0210 | 1.446 ± 0.0252 | 1.499 ± 0.0249 |
| Day 15, minute 5 (n=135, 65, 73) | 1.494 ± 0.0246 | 1.421 ± 0.0315 | 1.490 ± 0.0299 |
| Day 15, minute 15 (n=133, 70, 72) | 1.530 ± 0.0246 | 1.411 ± 0.0307 | 1.537 ± 0.0303 |
| Day 15, minute 30 (n= 139, 70, 74) | 1.551 ± 0.0236 | 1.417 ± 0.0297 | 1.516 ± 0.0289 |
| Day 15, hour 1 (n=140, 68, 74) | 1.575 ± 0.0242 | 1.409 ± 0.0305 | 1.540 ± 0.0296 |
| Week 5, minute 5 (n=134, 66, 68) | 1.550 ± 0.0247 | 1.448 ± 0.0319 | 1.525 ± 0.0305 |
| Week 5, minute 15 (n=136, 67, 70) | 1.575 ± 0.0239 | 1.452 ± 0.0305 | 1.543 ± 0.0295 |
| Week 5, minute 30 (n=135, 67, 70) | 1.630 ± 0.0260 | 1.481 ± 0.0327 | 1.584 ± 0.0317 |
| Week 9, minute 5 (n=128, 66, 70) | 1.562 ± 0.0268 | 1.417 ± 0.0341 | 1.520 ± 0.0326 |
| Week 9, minute 15 (n=130, 66, 71) | 1.583 ± 0.0267 | 1.441 ± 0.0340 | 1.534 ± 0.0326 |
| Week 9, minute 30 (n=130, 67, 71) | 1.603 ± 0.0265 | 1.427 ± 0.0335 | 1.549 ± 0.0323 |
| Week 12, minute 5 (n=130, 69, 70) | 1.497 ± 0.0254 | 1.385 ± 0.0319 | 1.474 ± 0.0315 |
| Week 12, minute 15 (n=129, 67, 66) | 1.523 ± 0.0251 | 1.373 ± 0.0317 | 1.481 ± 0.0315 |
| Week 12, minute 30 (n=133, 69, 67) | 1.517 ± 0.0275 | 1.362 ± 0.0336 | 1.488 ± 0.0335 |
| Week 12, hour 1 (n=132, 67, 69) | 1.557 ± 0.0273 | 1.369 ± 0.0341 | 1.519 ± 0.0333 |
| Week 12, hour 2 (n=129, 65, 68) | 1.596 ± 0.0290 | 1.434 ± 0.0365 | 1.565 ± 0.0353 |
| Week 12, hour 3 (n=126, 64, 69) | 1.600 ± 0.0291 | 1.443 ± 0.0375 | 1.566 ± 0.0353 |
| Week 12, hour 4 (n=124, 64, 68) | 1.584 ± 0.0319 | 1.442 ± 0.0407 | 1.535 ± 0.0383 |
| Week 12, hour 6 (n=123, 63, 69) | 1.558 ± 0.0321 | 1.443 ± 0.0407 | 1.520 ± 0.0381 |
| Week 12, hour 8 (n=121, 64, 69) | 1.535 ± 0.0310 | 1.408 ± 0.0385 | 1.479 ± 0.0374 |
| Week 12, hour 10 (n=124, 61, 69) | 1.541 ± 0.0296 | 1.435 ± 0.0392 | 1.532 ± 0.0365 |
| Week 12, hour 12 (n=122, 58, 68) | 1.522 ± 0.0313 | 1.422 ± 0.0417 | 1.487 ± 0.0382 |
| Week 12, hour 16 (n=109, 56, 57) | 1.431 ± 0.0320 | 1.360 ± 0.0425 | 1.378 ± 0.0404 |
| Week 12, hour 22 (n=117, 60, 63) | 1.420 ± 0.0268 | 1.349 ± 0.0350 | 1.371 ± 0.0333 |
| Week 12, hour 23, minute 15 (n=126, 66, 67) | 1.518 ± 0.0269 | 1.456 ± 0.0345 | 1.520 ± 0.0335 |
| Week 12, hour 23, minute 45 (n=124, 65, 63) | 1.513 ± 0.0294 | 1.470 ± 0.0377 | 1.488 ± 0.0374 |
| Week 16, minute 5 (n=123, 65, 64) | 1.538 ± 0.0296 | 1.430 ± 0.0362 | 1.515 ± 0.0359 |
| Week 16, minute 15 (n=124, 65, 65) | 1.557 ± 0.0309 | 1.422 ± 0.0380 | 1.530 ± 0.0377 |
| Week 16, minute 30 (n=125, 65, 65) | 1.570 ± 0.0303 | 1.409 ± 0.0370 | 1.535 ± 0.0368 |
| Week 20, minute 5 (n=125, 66, 63) | 1.518 ± 0.0281 | 1.393 ± 0.0348 | 1.453 ± 0.0351 |
| Week 20, minute 15 (n=124, 65, 63) | 1.535 ± 0.0285 | 1.380 ± 0.0354 | 1.479 ± 0.0356 |
| Week 20, minute 30 (n=125, 65, 63) | 1.576 ± 0.0277 | 1.391 ± 0.0349 | 1.502 ± 0.0350 |
| Week 26, minute 5 (n=123, 62, 64) | 1.483 ± 0.0278 | 1.361 ± 0.0368 | 1.415 ± 0.0352 |
| Week 26, minute 15 (n=121, 61, 61) | 1.521 ± 0.0280 | 1.377 ± 0.0373 | 1.464 ± 0.0358 |
| Week 26, minute 30 (n=125, 64, 64) | 1.529 ± 0.0285 | 1.353 ± 0.0372 | 1.439 ± 0.0359 |
| Week 26, hour 1 (n=127, 64, 64) | 1.546 ± 0.0275 | 1.364 ± 0.0359 | 1.462 ± 0.0349 |
| Week 26, hour 2 (n=124, 64, 63) | 1.590 ± 0.0317 | 1.422 ± 0.0403 | 1.520 ± 0.0395 |
| Week 26, hour 3 (n=124, 64, 64) | 1.614 ± 0.0303 | 1.442 ± 0.0391 | 1.555 ± 0.0380 |
| Week 26, hour 4 (n=124, 64, 62) | 1.577 ± 0.0304 | 1.416 ± 0.0384 | 1.519 ± 0.0377 |
| Week 26, hour 23, minute 15 (n=120, 55, 61) | 1.477 ± 0.0323 | 1.374 ± 0.0422 | 1.416 ± 0.0399 |
| Week 26, hour 23, minute 45 (n=117, 56, 61) | 1.483 ± 0.0296 | 1.401 ± 0.0395 | 1.405 ± 0.0376 |
| Week 34, minute 5 (n=125, 62, 63) | 1.515 ± 0.0293 | 1.359 ± 0.0385 | 1.407 ± 0.0372 |
| Week 34, minute 15 (n=123, 62, 63) | 1.529 ± 0.0300 | 1.360 ± 0.0394 | 1.425 ± 0.0379 |
| Week 34, minute 30 (n=125, 62, 62) | 1.567 ± 0.0302 | 1.353 ± 0.0398 | 1.452 ± 0.0385 |
| Week 34, hour 1 (n=125, 62, 63) | 1.557 ± 0.0285 | 1.352 ± 0.0376 | 1.472 ± 0.0361 |
| Week 42, minute 5 (n=119, 61, 58) | 1.512 ± 0.0305 | 1.394 ± 0.0401 | 1.490 ± 0.0394 |
| Week 42, minute 15 (n=123, 61, 58) | 1.520 ± 0.0305 | 1.412 ± 0.0403 | 1.491 ± 0.0396 |
| Week 42, minute 30 (n=123, 61, 58) | 1.537 ± 0.0332 | 1.391 ± 0.0431 | 1.517 ± 0.0424 |
| Week 50, minute 5 (n=120, 60, 57) | 1.490 ± 0.0269 | 1.357 ± 0.0348 | 1.422 ± 0.0341 |
| Week 50, minute 15 (n=123, 60, 57) | 1.529 ± 0.0285 | 1.375 ± 0.0369 | 1.452 ± 0.0362 |
| Week 50, minute 30 (n=123, 60, 58) | 1.545 ± 0.0287 | 1.368 ± 0.0375 | 1.470 ± 0.0366 |
| Week 52, minute 5 (n=124, 60, 57) | 1.456 ± 0.0276 | 1.337 ± 0.0368 | 1.377 ± 0.0359 |
| Week 52, minute 15 (n=122, 59, 58) | 1.502 ± 0.0282 | 1.380 ± 0.0378 | 1.428 ± 0.0364 |
| Week 52, minute 30 (n=125, 62, 58) | 1.483 ± 0.0280 | 1.366 ± 0.0370 | 1.407 ± 0.0362 |
| Week 52, hour 1 (n=125, 62, 57) | 1.525 ± 0.0271 | 1.356 ± 0.0359 | 1.439 ± 0.0352 |
| Week 52, hour 2 (n=124, 61, 58) | 1.554 ± 0.0295 | 1.418 ± 0.0393 | 1.479 ± 0.0382 |
| Week 52, hour 3 (n=123, 62, 56) | 1.558 ± 0.0263 | 1.384 ± 0.0349 | 1.487 ± 0.0345 |
| Week 52, hour 4 (n=121, 60, 55) | 1.535 ± 0.0297 | 1.381 ± 0.0395 | 1.468 ± 0.0390 |
| Week 52, hour 6 (n=118, 59, 54) | 1.494 ± 0.0294 | 1.370 ± 0.0392 | 1.461 ± 0.0388 |
| Week 52, hour 8 (n=119, 59, 54) | 1.473 ± 0.0300 | 1.358 ± 0.0398 | 1.418 ± 0.0394 |
| Week 52, hour 10 (n=119, 59, 55) | 1.478 ± 0.0304 | 1.349 ± 0.0397 | 1.419 ± 0.0391 |
| Week 52, hour 12 (n=120, 58, 52) | 1.451 ± 0.0334 | 1.369 ± 0.0446 | 1.347 ± 0.0444 |
| Week 52, hour 16 (n=117, 53, 46) | 1.377 ± 0.0309 | 1.277 ± 0.0422 | 1.329 ± 0.0420 |
| Week 52, hour 22 (n=118, 60, 52) | 1.391 ± 0.0302 | 1.314 ± 0.0397 | 1.282 ± 0.0396 |
| Week 52, hour 23, 15 minutes (n=121, 62, 57) | 1.447 ± 0.0287 | 1.362 ± 0.0378 | 1.387 ± 0.0371 |
| Week 52, hour 23, 45 minutes (n=122, 61, 57) | 1.434 ± 0.0281 | 1.337 ± 0.0372 | 1.359 ± 0.0364 |
Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told "At the end of the next normal breath out, take a deep breath all the way in"; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Day 1, minute 5 (n=135, 74, 74) | 3.027 ± 0.0304 | 2.826 ± 0.0363 | 2.956 ± 0.0363 |
| Day 1, minute 15 (n=139, 75, 74) | 3.050 ± 0.0335 | 2.802 ± 0.0403 | 2.991 ± 0.0406 |
| Day 1, minute 30 (n=143, 77, 74) | 3.055 ± 0.0343 | 2.752 ± 0.0416 | 2.979 ± 0.0422 |
| Day 1, hour 1 (n=144, 76, 75) | 3.148 ± 0.0377 | 2.791 ± 0.0460 | 3.041 ± 0.0463 |
| Day 1, hour 2 (n=144, 75, 75) | 3.179 ± 0.0373 | 2.802 ± 0.0460 | 3.049 ± 0.0461 |
| Day 1, hour 3 (n=143, 74, 73) | 3.190 ± 0.0433 | 2.826 ± 0.0526 | 3.119 ± 0.0531 |
| Day 1, hour 4 (n=144, 70, 74) | 3.138 ± 0.0414 | 2.783 ± 0.0515 | 3.102 ± 0.0512 |
| Day 1, hour 6 (n=142, 71, 74) | 3.173 ± 0.0419 | 2.846 ± 0.0514 | 3.148 ± 0.0513 |
| Day 1, hour 8 (n=137, 70, 75) | 3.071 ± 0.0404 | 2.804 ± 0.0506 | 3.074 ± 0.0498 |
| Day1, hour 10 (n=134, 72, 75) | 3.134 ± 0.0414 | 2.865 ± 0.0514 | 3.119 ± 0.0510 |
| Day 1, hour 12 (n=130, 69, 70) | 3.030 ± 0.0444 | 2.709 ± 0.0535 | 3.012 ± 0.0537 |
| Day 1, hour 23, minute 15 (n=129, 71, 72) | 2.991 ± 0.0385 | 2.800 ± 0.0478 | 2.988 ± 0.0471 |
| Day 1, hour 23, minute 45 (n=128, 74, 75) | 3.014 ± 0.0364 | 2.817 ± 0.0444 | 2.994 ± 0.0442 |
| Day 15, minute 5 (n=135, 65, 73) | 3.051 ± 0.0439 | 2.793 ± 0.0553 | 3.014 ± 0.0534 |
| Day 15, minute 15 (n=133, 70, 72) | 3.103 ± 0.0443 | 2.790 ± 0.0536 | 3.103 ± 0.0536 |
| Day 15, minute 30 (n= 139, 70, 74) | 3.134 ± 0.0420 | 2.825 ± 0.0519 | 3.078 ± 0.0513 |
| Day 15, hour 1 (n=140, 68, 74) | 3.152 ± 0.0434 | 2.770 ± 0.0537 | 3.060 ± 0.0528 |
| Week 5, minute 5 (n=134, 66, 68) | 3.139 ± 0.0430 | 2.866 ± 0.0551 | 3.071 ± 0.0534 |
| Week 5, minute 15 (n=136, 67, 70) | 3.165 ± 0.0501 | 2.850 ± 0.0611 | 3.092 ± 0.0602 |
| Week 5, minute 30 (n=135, 67, 70) | 3.248 ± 0.0540 | 2.884 ± 0.0644 | 3.180 ± 0.0636 |
| Week 9, minute 5 (n=128, 66, 70) | 3.195 ± 0.0543 | 2.826 ± 0.0644 | 3.097 ± 0.0632 |
| Week 9, minute 15 (n=130, 66, 71) | 3.167 ± 0.0507 | 2.823 ± 0.0615 | 3.101 ± 0.0603 |
| Week 9, minute 30 (n=130, 67, 71) | 3.231 ± 0.0567 | 2.821 ± 0.0675 | 3.149 ± 0.0664 |
| Week 12, minute 5 (n=130, 69, 70) | 3.060 ± 0.0492 | 2.728 ± 0.0596 | 3.023 ± 0.0596 |
| Week 12, minute 15 (n=129, 67, 66) | 3.081 ± 0.0482 | 2.740 ± 0.0588 | 3.018 ± 0.0593 |
| Week 12, minute 30 (n=133, 69, 67) | 3.058 ± 0.0479 | 2.696 ± 0.0585 | 3.027 ± 0.0591 |
| Week 12, hour 1 (n=132, 67, 69) | 3.164 ± 0.0543 | 2.737 ± 0.0663 | 3.098 ± 0.0655 |
| Week 12, hour 2 (n=129, 65, 68) | 3.190 ± 0.0526 | 2.784 ± 0.0664 | 3.155 ± 0.0649 |
| Week 12, hour 3 (n=126, 64, 69) | 3.240 ± 0.0569 | 2.864 ± 0.0713 | 3.146 ± 0.0685 |
| Week 12, hour 4 (n=124, 64, 68) | 3.119 ± 0.0576 | 2.745 ± 0.0714 | 3.084 ± 0.0686 |
| Week 12, hour 6 (n=123, 63, 69) | 3.158 ± 0.0594 | 2.852 ± 0.0731 | 3.120 ± 0.0700 |
| Week 12, hour 8 (n=121, 64, 69) | 3.083 ± 0.0534 | 2.760 ± 0.0657 | 3.011 ± 0.0644 |
| Week 12, hour 10 (n=124, 61, 69) | 3.130 ± 0.0581 | 2.860 ± 0.0722 | 3.117 ± 0.0692 |
| Week 12, hour 12 (n=122, 58, 68) | 3.072 ± 0.0599 | 2.771 ± 0.0770 | 3.020 ± 0.0722 |
| Week 12, hour 16 (n=109, 56, 57) | 2.933 ± 0.0645 | 2.701 ± 0.0800 | 2.880 ± 0.0785 |
| Week 12, hour 22 (n=117, 60, 63) | 2.924 ± 0.0517 | 2.673 ± 0.0647 | 2.870 ± 0.0629 |
| Week 12, hour 23, minute 15 (n=126, 66, 67) | 3.091 ± 0.0548 | 2.862 ± 0.0676 | 3.110 ± 0.0671 |
| Week 12, hour 23, minute 45 (n=124, 65, 63) | 3.055 ± 0.0507 | 2.826 ± 0.0630 | 3.004 ± 0.0638 |
| Week 16, minute 5 (n=123, 65, 64) | 3.156 ± 0.0608 | 2.864 ± 0.0719 | 3.104 ± 0.0723 |
| Week 16, minute 15 (n=124, 65, 65) | 3.156 ± 0.0576 | 2.801 ± 0.0695 | 3.082 ± 0.0699 |
| Week 16, minute 30 (n=125, 65, 65) | 3.198 ± 0.0552 | 2.815 ± 0.0676 | 3.112 ± 0.0679 |
| Week 20, minute 5 (n=125, 66, 63) | 3.093 ± 0.0526 | 2.781 ± 0.0630 | 2.993 ± 0.0643 |
| Week 20, minute 15 (n=124, 65, 63) | 3.112 ± 0.0545 | 2.770 ± 0.0655 | 3.029 ± 0.0666 |
| Week 20, minute 30 (n=125, 65, 63) | 3.157 ± 0.0559 | 2.778 ± 0.0677 | 3.050 ± 0.0688 |
| Week 26, minute 5 (n=123, 62, 64) | 2.994 ± 0.0528 | 2.700 ± 0.0670 | 2.954 ± 0.0658 |
| Week 26, minute 15 (n=121, 61, 61) | 3.041 ± 0.0513 | 2.692 ± 0.0652 | 2.976 ± 0.0644 |
| Week 26, minute 30 (n=125, 64, 64) | 3.054 ± 0.0464 | 2.700 ± 0.0597 | 2.994 ± 0.0589 |
| Week 26, hour 1 (n=127, 64, 64) | 3.077 ± 0.0520 | 2.678 ± 0.0658 | 3.016 ± 0.0651 |
| Week 26, hour 2 (n=124, 64, 63) | 3.110 ± 0.0516 | 2.771 ± 0.0655 | 3.080 ± 0.0650 |
| Week 26, hour 3 (n=124, 64, 64) | 3.210 ± 0.0648 | 2.871 ± 0.0765 | 3.176 ± 0.0762 |
| Week 26, hour 4 (n=124, 64, 62) | 3.111 ± 0.0551 | 2.791 ± 0.0664 | 3.086 ± 0.0664 |
| Week 26, hour 23, minute 15 (n=120, 55, 61) | 3.056 ± 0.0600 | 2.803 ± 0.0749 | 2.932 ± 0.0721 |
| Week 26, hour 23, minute 45 (n=117, 56, 61) | 2.998 ± 0.0512 | 2.752 ± 0.0667 | 2.895 ± 0.0646 |
| Week 34, minute 5 (n=125, 62, 63) | 3.023 ± 0.0573 | 2.731 ± 0.0715 | 2.881 ± 0.0706 |
| Week 34, minute 15 (n=123, 62, 63) | 3.016 ± 0.0553 | 2.731 ± 0.0691 | 2.898 ± 0.0683 |
| Week 34, minute 30 (n=125, 62, 62) | 3.081 ± 0.0555 | 2.687 ± 0.0715 | 2.971 ± 0.0708 |
| Week 34, hour 1 (n=125, 62, 63) | 3.072 ± 0.0564 | 2.703 ± 0.0707 | 2.963 ± 0.0699 |
| Week 42, minute 5 (n=119, 61, 58) | 3.033 ± 0.0583 | 2.716 ± 0.0744 | 3.069 ± 0.0746 |
| Week 42, minute 15 (n=123, 61, 58) | 3.022 ± 0.0539 | 2.695 ± 0.0706 | 3.065 ± 0.0699 |
| Week 42, minute 30 (n=123, 61, 58) | 3.057 ± 0.0565 | 2.723 ± 0.0734 | 3.098 ± 0.0734 |
| Week 50, minute 5 (n=120, 60, 57) | 3.022 ± 0.0596 | 2.731 ± 0.0727 | 2.963 ± 0.0726 |
| Week 50, minute 15 (n=123, 60, 57) | 3.042 ± 0.0592 | 2.702 ± 0.0726 | 2.937 ± 0.0725 |
| Week 50, minute 30 (n=123, 60, 58) | 3.094 ± 0.0613 | 2.731 ± 0.0749 | 2.985 ± 0.0747 |
| Week 52, minute 5 (n=124, 60, 57) | 2.940 ± 0.0551 | 2.645 ± 0.0701 | 2.860 ± 0.0702 |
| Week 52, minute 15 (n=122, 59, 58) | 2.960 ± 0.0518 | 2.640 ± 0.0675 | 2.935 ± 0.0666 |
| Week 52, minute 30 (n=125, 62, 58) | 2.939 ± 0.0499 | 2.625 ± 0.0650 | 2.929 ± 0.0652 |
| Week 52, hour 1 (n=125, 62, 57) | 3.031 ± 0.0564 | 2.617 ± 0.0698 | 2.980 ± 0.0704 |
| Week 52, hour 2 (n=124, 61, 58) | 3.062 ± 0.0556 | 2.714 ± 0.0689 | 3.021 ± 0.0689 |
| Week 52, hour 3 (n=123, 62, 56) | 3.108 ± 0.0648 | 2.716 ± 0.0766 | 3.053 ± 0.0779 |
| Week 52, hour 4 (n=121, 60, 55) | 3.021 ± 0.0585 | 2.694 ± 0.0724 | 2.978 ± 0.0735 |
| Week 52, hour 6 (n=118, 59, 54) | 2.986 ± 0.0614 | 2.690 ± 0.0770 | 2.982 ± 0.0781 |
| Week 52, hour 8 (n=119, 59, 54) | 2.961 ± 0.0646 | 2.637 ± 0.0793 | 2.942 ± 0.0805 |
| Week 52, hour 10 (n=119, 59, 55) | 3.000 ± 0.0701 | 2.687 ± 0.0840 | 3.012 ± 0.0844 |
| Week 52, hour 12 (n=120, 58, 52) | 2.881 ± 0.0631 | 2.636 ± 0.0831 | 2.849 ± 0.0847 |
| Week 52, hour 16 (n=117, 53, 46) | 2.857 ± 0.0694 | 2.542 ± 0.0857 | 2.772 ± 0.0873 |
| Week 52, hour 22 (n=118, 60, 52) | 2.812 ± 0.0670 | 2.604 ± 0.0810 | 2.716 ± 0.0827 |
| Week 52, hour 23, 15 minutes (n=121, 62, 57) | 2.888 ± 0.0595 | 2.678 ± 0.0751 | 2.852 ± 0.0755 |
| Week 52, hour 23, 45 minutes (n=122, 61, 57) | 2.855 ± 0.0558 | 2.607 ± 0.0700 | 2.797 ± 0.0702 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Day 1, minute 5 (n=495, 255, 253) | 1.443 ± 0.0067 | 1.357 ± 0.0081 | 1.402 ± 0.0081 |
| Day 1, minute 15 (n=502, 255, 254) | 1.501 ± 0.0074 | 1.359 ± 0.0090 | 1.437 ± 0.0090 |
| Day 1, minute 30 (n=507, 252, 254) | 1.524 ± 0.0103 | 1.357 ± 0.0126 | 1.468 ± 0.0125 |
| Day 1, hour 1 (n=511, 256, 254) | 1.552 ± 0.0082 | 1.353 ± 0.0101 | 1.484 ± 0.0101 |
| Day 1, hour 2 (n=513, 253, 252) | 1.612 ± 0.0090 | 1.397 ± 0.0113 | 1.549 ± 0.0112 |
| Day 1, hour 3 (n=510, 248, 252) | 1.590 ± 0.0088 | 1.389 ± 0.0111 | 1.560 ± 0.0109 |
| Day 1, hour 4 (n=504, 239, 250) | 1.590 ± 0.0095 | 1.396 ± 0.0121 | 1.549 ± 0.0117 |
| Day 1, hour 23, minute 15 (n=481, 243, 239) | 1.459 ± 0.0093 | 1.364 ± 0.0115 | 1.457 ± 0.0115 |
| Day 1, hour 23, minute 45 (n=474, 239, 232) | 1.482 ± 0.0094 | 1.390 ± 0.0117 | 1.473 ± 0.0118 |
| Day 15, minute 5 (n=498, 223, 243) | 1.491 ± 0.0123 | 1.368 ± 0.0157 | 1.472 ± 0.0151 |
| Day 15, minute 15 (n=487, 229, 239) | 1.527 ± 0.0123 | 1.371 ± 0.0154 | 1.514 ± 0.0151 |
| Day 15, minute 30 (n=503, 233, 242) | 1.538 ± 0.0122 | 1.368 ± 0.0152 | 1.504 ± 0.0150 |
| Day 15, hour 1 (n=501, 229, 240) | 1.561 ± 0.0121 | 1.379 ± 0.0153 | 1.525 ± 0.0150 |
| Week 5, minute 5 (n=476, 221, 231) | 1.509 ± 0.0125 | 1.371 ± 0.0161 | 1.488 ± 0.0157 |
| Week 5, minute 15 (n=479, 222, 234) | 1.538 ± 0.0126 | 1.389 ± 0.0162 | 1.508 ± 0.0157 |
| Week 5, minute 30 (n=480, 223, 234) | 1.564 ± 0.0129 | 1.396 ± 0.0165 | 1.525 ± 0.0160 |
| Week 9, minute 5 (n=454, 217, 227) | 1.529 ± 0.0126 | 1.366 ± 0.0159 | 1.499 ± 0.0157 |
| Week 9, minute 15 (n=459, 220, 225) | 1.550 ± 0.0132 | 1.376 ± 0.0164 | 1.515 ± 0.0163 |
| Week 9, minute 30 (n=460, 220, 226) | 1.569 ± 0.0125 | 1.378 ± 0.0158 | 1.531 ± 0.0157 |
| Week 12, minute 5 (n=453, 212, 230) | 1.502 ± 0.0136 | 1.349 ± 0.0173 | 1.477 ± 0.0167 |
| Week 12, minute 15 (n=448, 205, 222) | 1.527 ± 0.0131 | 1.352 ± 0.0171 | 1.501 ± 0.0166 |
| Week 12, minute 30 (n=455, 212, 226) | 1.522 ± 0.0139 | 1.352 ± 0.0176 | 1.491 ± 0.0170 |
| Week 12, hour 1 (n=455, 210, 227) | 1.556 ± 0.0139 | 1.364 ± 0.0178 | 1.528 ± 0.0171 |
| Week 12, hour 2 (n=446, 207, 225) | 1.595 ± 0.0145 | 1.423 ± 0.0185 | 1.558 ± 0.0178 |
| Week 12, hour 3 (n=444, 204, 225) | 1.592 ± 0.0145 | 1.414 ± 0.0186 | 1.561 ± 0.0177 |
| Week 12, hour 4 (n=437, 202, 224) | 1.558 ± 0.0152 | 1.416 ± 0.0193 | 1.534 ± 0.0183 |
| Week 12, hour 23, minute 15 (n=430, 200, 214) | 1.481 ± 0.0143 | 1.381 ± 0.0183 | 1.457 ± 0.0177 |
| Week 12, hour 23, minute 45 (n=426, 195, 205) | 1.493 ± 0.0149 | 1.413 ± 0.0190 | 1.472 ± 0.0187 |
| Week 16, minute 5 (n=429, 207, 218) | 1.514 ± 0.0151 | 1.373 ± 0.0185 | 1.487 ± 0.0181 |
| Week 16, minute 15 (n=428, 209, 219) | 1.530 ± 0.0155 | 1.372 ± 0.0189 | 1.491 ± 0.0186 |
| Week 16, minute 30 (n=433, 209, 220) | 1.546 ± 0.0160 | 1.372 ± 0.0194 | 1.505 ± 0.0190 |
| Week 20, minute 5 (n=430, 206, 218) | 1.495 ± 0.0159 | 1.351 ± 0.0198 | 1.464 ± 0.0192 |
| Week 20, minute 15 (n=430, 207, 220) | 1.525 ± 0.0164 | 1.362 ± 0.0203 | 1.495 ± 0.0196 |
| Week 20, minute 30 (n=431, 207, 221) | 1.544 ± 0.0164 | 1.362 ± 0.0203 | 1.498 ± 0.0195 |
| Week 26, minute 5 (421, 202, 213) | 1.479 ± 0.0153 | 1.339 ± 0.0189 | 1.429 ± 0.0185 |
| Week 26, minute 15 (n=414, 200, 207) | 1.504 ± 0.0155 | 1.340 ± 0.0193 | 1.458 ± 0.0191 |
| Week 26, minute 30 (n=424, 206, 213) | 1.513 ± 0.0161 | 1.341 ± 0.0196 | 1.451 ± 0.0193 |
| Week 26, hour 1 (n=425, 206, 212) | 1.541 ± 0.0160 | 1.345 ± 0.0193 | 1.487 ± 0.0190 |
| Week 26, hour 2 (n=420, 203, 208) | 1.570 ± 0.0176 | 1.388 ± 0.0212 | 1.524 ± 0.0210 |
| Week 26, hour 3 (n=416, 204, 213) | 1.570 ± 0.0181 | 1.398 ± 0.0216 | 1.526 ± 0.0211 |
| Week 26, hour 4 (n=416, 203, 208) | 1.547 ± 0.0175 | 1.384 ± 0.0211 | 1.504 ± 0.0208 |
| Week 26, hour 23, minute 15 (n=405, 187, 202) | 1.464 ± 0.0175 | 1.326 ± 0.0217 | 1.415 ± 0.0212 |
| Week 26, hour 23, minute 45 (n=401, 185, 198) | 1.474 ± 0.0175 | 1.354 ± 0.0218 | 1.426 ± 0.0215 |
| Week 34, minute 5 (n=408, 194, 212) | 1.481 ± 0.0167 | 1.338 ± 0.0210 | 1.422 ± 0.0202 |
| Week 34, minute 15 (n=407, 191, 214) | 1.508 ± 0.0172 | 1.333 ± 0.0215 | 1.443 ± 0.0206 |
| Week 34, minute 30 (n=410, 196, 215) | 1.518 ± 0.0172 | 1.331 ± 0.0214 | 1.444 ± 0.0206 |
| Week 34, hour 1 (n=412, 195, 215) | 1.534 ± 0.0171 | 1.331 ± 0.0213 | 1.464 ± 0.0205 |
| Week 42, minute 5 (n=398, 189, 199) | 1.489 ± 0.0172 | 1.342 ± 0.0218 | 1.459 ± 0.0213 |
| Week 42, minute 15 (n=405, 188, 201) | 1.511 ± 0.0171 | 1.344 ± 0.0218 | 1.477 ± 0.0211 |
| Week 42, minute 30 (n=405, 189, 201) | 1.518 ± 0.0183 | 1.350 ± 0.0229 | 1.496 ± 0.0222 |
| Week 50, minute 5 (n=386, 185, 199) | 1.454 ± 0.0155 | 1.336 ± 0.0197 | 1.429 ± 0.0190 |
| Week 50, minute 15 (n=391, 187, 203) | 1.496 ± 0.0156 | 1.341 ± 0.0199 | 1.462 ± 0.0192 |
| Week 50, minute 30 (n=392, 186, 204) | 1.504 ± 0.0166 | 1.341 ± 0.0210 | 1.475 ± 0.0200 |
| Week 52, minute 5 (n=401, 188, 197) | 1.436 ± 0.0155 | 1.305 ± 0.0200 | 1.419 ± 0.0195 |
| Week 52, minute 15 (n=394, 183, 200) | 1.471 ± 0.0159 | 1.323 ± 0.0208 | 1.451 ± 0.0198 |
| Week 52, minute 30 (n=402, 189, 202) | 1.471 ± 0.0164 | 1.319 ± 0.0209 | 1.451 ± 0.0202 |
| Week 52, hour 1 (n=404, 190, 201) | 1.499 ± 0.0161 | 1.325 ± 0.0205 | 1.482 ± 0.0198 |
| Week 52, hour 2 (n=402, 186, 202) | 1.526 ± 0.0177 | 1.363 ± 0.0224 | 1.511 ± 0.0214 |
| Week 52, hour 3 (n=400, 186, 199) | 1.525 ± 0.0171 | 1.344 ± 0.0215 | 1.509 ± 0.0207 |
| Week 52, hour 4 (n=397, 184, 199) | 1.504 ± 0.0176 | 1.346 ± 0.0222 | 1.501 ± 0.0213 |
| Week 52, hour 23, minute 15 (n=388, 183, 198) | 1.419 ± 0.0169 | 1.303 ± 0.0215 | 1.397 ± 0.0205 |
| Week 52, hour 23, minute 45 (n=395, 185, 199) | 1.424 ± 0.0165 | 1.320 ± 0.0210 | 1.411 ± 0.0201 |
Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told "At the end of the next normal breath out, take a deep breath all the way in"; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Day 1, minute 5 (n=495, 255, 253) | 2.915 ± 0.0145 | 2.731 ± 0.0174 | 2.856 ± 0.0174 |
| Day 1, minute 15 (n=502, 255, 254) | 2.982 ± 0.0164 | 2.719 ± 0.0199 | 2.903 ± 0.0198 |
| Day 1, minute 30 (n=507, 252, 254) | 3.004 ± 0.0177 | 2.692 ± 0.0219 | 2.937 ± 0.0217 |
| Day 1, hour 1 (n=511, 256, 254) | 3.074 ± 0.0173 | 2.732 ± 0.0214 | 2.975 ± 0.0213 |
| Day 1, hour 2 (n=513, 253, 252) | 3.119 ± 0.0182 | 2.762 ± 0.0227 | 3.033 ± 0.0226 |
| Day 1, hour 3 (n=510, 248, 252) | 3.129 ± 0.0193 | 2.811 ± 0.0243 | 3.073 ± 0.0239 |
| Day 1, hour 4 (n=504, 239, 250) | 3.076 ± 0.0192 | 2.767 ± 0.0244 | 3.031 ± 0.0237 |
| Day 1, hour 23, minute 15 (n=481, 243, 239) | 2.926 ± 0.0178 | 2.745 ± 0.0220 | 2.923 ± 0.0220 |
| Day 1, hour 23, minute 45 (n=474, 239, 232) | 2.930 ± 0.0178 | 2.749 ± 0.0221 | 2.923 ± 0.0224 |
| Day 15, minute 5 (n=498, 223, 243) | 2.984 ± 0.0222 | 2.760 ± 0.0282 | 2.980 ± 0.0272 |
| Day 15, minute 15 (n=487, 229, 239) | 3.016 ± 0.0220 | 2.748 ± 0.0274 | 3.030 ± 0.0270 |
| Day 15, minute 30 (n=503, 233, 242) | 3.028 ± 0.0212 | 2.756 ± 0.0269 | 3.018 ± 0.0265 |
| Day 15, hour 1 (n=501, 229, 240) | 3.068 ± 0.0213 | 2.757 ± 0.0271 | 3.023 ± 0.0267 |
| Week 5, minute 5 (n=476, 221, 231) | 3.004 ± 0.0215 | 2.768 ± 0.0277 | 3.011 ± 0.0270 |
| Week 5, minute 15 (n=479, 222, 234) | 3.024 ± 0.0234 | 2.771 ± 0.0294 | 3.024 ± 0.0286 |
| Week 5, minute 30 (n=480, 223, 234) | 3.085 ± 0.0243 | 2.804 ± 0.0305 | 3.063 ± 0.0297 |
| Week 9, minute 5 (n=454, 217, 227) | 3.047 ± 0.0262 | 2.767 ± 0.0313 | 3.029 ± 0.0309 |
| Week 9, minute 15 (n=459, 220, 225) | 3.050 ± 0.0257 | 2.764 ± 0.0312 | 3.046 ± 0.0311 |
| Week 9, minute 30 (n=460, 220, 226) | 3.079 ± 0.0265 | 2.768 ± 0.0322 | 3.079 ± 0.0319 |
| Week 12, minute 5 (n=453, 212, 230) | 2.991 ± 0.0253 | 2.726 ± 0.0313 | 2.978 ± 0.0304 |
| Week 12, minute 15 (n=448, 205, 222) | 3.003 ± 0.0252 | 2.735 ± 0.0316 | 3.004 ± 0.0307 |
| Week 12, minute 30 (n=455, 212, 226) | 2.985 ± 0.0251 | 2.707 ± 0.0314 | 2.987 ± 0.0306 |
| Week 12, hour 1 (n=455, 210, 227) | 3.062 ± 0.0267 | 2.741 ± 0.0333 | 3.048 ± 0.0322 |
| Week 12, hour 2 (n=446, 207, 225) | 3.093 ± 0.0266 | 2.801 ± 0.0335 | 3.065 ± 0.0324 |
| Week 12, hour 3 (n=444, 204, 225) | 3.129 ± 0.0275 | 2.839 ± 0.0346 | 3.096 ± 0.0332 |
| Week 12, hour 4 (n=437, 202, 224) | 3.050 ± 0.0278 | 2.793 ± 0.0349 | 3.054 ± 0.0333 |
| Week 12, hour 23, minute 15 (n=430, 200, 214) | 2.991 ± 0.0282 | 2.799 ± 0.0349 | 2.985 ± 0.0341 |
| Week 12, hour 23, minute 45 (n=426, 195, 205) | 2.977 ± 0.0268 | 2.799 ± 0.0336 | 2.946 ± 0.0332 |
| Week 16, minute 5 (n=429, 207, 218) | 3.016 ± 0.0301 | 2.753 ± 0.0362 | 3.009 ± 0.0355 |
| Week 16, minute 15 (n=428, 209, 219) | 3.029 ± 0.0293 | 2.737 ± 0.0353 | 3.002 ± 0.0348 |
| Week 16, minute 30 (n=433, 209, 220) | 3.063 ± 0.0298 | 2.747 ± 0.0359 | 3.036 ± 0.0353 |
| Week 20, minute 5 (n=430, 206, 218) | 2.985 ± 0.0286 | 2.744 ± 0.0349 | 2.966 ± 0.0338 |
| Week 20, minute 15 (n=430, 207, 220) | 3.020 ± 0.0293 | 2.749 ± 0.0356 | 2.994 ± 0.0345 |
| Week 20, minute 30 (n=431, 207, 221) | 3.058 ± 0.0309 | 2.774 ± 0.0374 | 3.028 ± 0.0362 |
| Week 26, minute 5 (421, 202, 213) | 2.956 ± 0.0289 | 2.733 ± 0.0352 | 2.945 ± 0.0345 |
| Week 26, minute 15 (n=414, 200, 207) | 2.980 ± 0.0298 | 2.713 ± 0.0363 | 2.959 ± 0.0360 |
| Week 26, minute 30 (n=424, 206, 213) | 2.983 ± 0.0282 | 2.715 ± 0.0342 | 2.949 ± 0.0337 |
| Week 26, hour 1 (n=425, 206, 212) | 3.034 ± 0.0293 | 2.721 ± 0.0352 | 2.997 ± 0.0346 |
| Week 26, hour 2 (n=420, 203, 208) | 3.049 ± 0.0308 | 2.777 ± 0.0370 | 3.036 ± 0.0366 |
| Week 26, hour 3 (n=416, 204, 213) | 3.097 ± 0.0331 | 2.831 ± 0.0389 | 3.065 ± 0.0381 |
| Week 26, hour 4 (n=416, 203, 208) | 3.022 ± 0.0312 | 2.776 ± 0.0369 | 3.021 ± 0.0364 |
| Week 26, hour 23, minute 15 (n=405, 187, 202) | 2.971 ± 0.0321 | 2.758 ± 0.0387 | 2.901 ± 0.0379 |
| Week 26, hour 23, minute 45 (n=401, 185, 198) | 2.952 ± 0.0305 | 2.759 ± 0.0373 | 2.883 ± 0.0368 |
| Week 34, minute 5 (n=408, 194, 212) | 2.967 ± 0.0321 | 2.713 ± 0.0387 | 2.919 ± 0.0374 |
| Week 34, minute 15 (n=407, 191, 214) | 2.983 ± 0.0327 | 2.718 ± 0.0392 | 2.948 ± 0.0376 |
| Week 34, minute 30 (n=410, 196, 215) | 3.002 ± 0.0333 | 2.690 ± 0.0400 | 2.947 ± 0.0386 |
| Week 34, hour 1 (n=412, 195, 215) | 3.014 ± 0.0336 | 2.711 ± 0.0400 | 2.959 ± 0.0385 |
| Week 42, minute 5 (n=398, 189, 199) | 2.982 ± 0.0344 | 2.727 ± 0.0415 | 2.983 ± 0.0406 |
| Week 42, minute 15 (n=405, 188, 201) | 3.001 ± 0.0336 | 2.713 ± 0.0410 | 3.001 ± 0.0398 |
| Week 42, minute 30 (n=405, 189, 201) | 3.016 ± 0.0345 | 2.734 ± 0.0419 | 3.021 ± 0.0408 |
| Week 50, minute 5 (n=386, 185, 199) | 2.925 ± 0.0328 | 2.729 ± 0.0393 | 2.942 ± 0.0381 |
| Week 50, minute 15 (n=391, 187, 203) | 2.971 ± 0.0330 | 2.729 ± 0.0398 | 2.962 ± 0.0384 |
| Week 50, minute 30 (n=392, 186, 204) | 2.999 ± 0.0342 | 2.731 ± 0.0409 | 2.998 ± 0.0394 |
| Week 52, minute 5 (n=401, 188, 197) | 2.899 ± 0.0309 | 2.673 ± 0.0377 | 2.916 ± 0.0367 |
| Week 52, minute 15 (n=394, 183, 200) | 2.942 ± 0.0314 | 2.701 ± 0.0389 | 2.969 ± 0.0371 |
| Week 52, minute 30 (n=402, 189, 202) | 2.923 ± 0.0325 | 2.666 ± 0.0391 | 2.962 ± 0.0378 |
| Week 52, hour 1 (n=404, 190, 201) | 2.992 ± 0.0339 | 2.696 ± 0.0405 | 3.011 ± 0.0393 |
| Week 52, hour 2 (n=402, 186, 202) | 2.997 ± 0.0354 | 2.727 ± 0.0421 | 3.005 ± 0.0405 |
| Week 52, hour 3 (n=400, 186, 199) | 3.029 ± 0.0359 | 2.742 ± 0.0427 | 3.020 ± 0.0413 |
| Week 52, hour 4 (n=397, 184, 199) | 2.984 ± 0.0359 | 2.725 ± 0.0425 | 2.991 ± 0.0410 |
| Week 52, hour 23, minute 15 (n=388, 183, 198) | 2.866 ± 0.0349 | 2.675 ± 0.0419 | 2.865 ± 0.0402 |
| Week 52, hour 23, minute 45 (n=395, 185, 199) | 2.869 ± 0.0342 | 2.694 ± 0.0406 | 2.868 ± 0.0390 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, and 4 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Day 1 | 1.570 ± 0.0075 | 1.373 ± 0.0092 | 1.514 ± 0.0092 |
| Week 12 (n=460, 214, 232) | 1.560 ± 0.0134 | 1.384 ± 0.0170 | 1.531 ± 0.0164 |
| Week 26 (n=430, 206, 216) | 1.546 ± 0.0160 | 1.369 ± 0.0194 | 1.495 ± 0.0190 |
| Week 52 (n=405, 192, 203) | 1.502 ± 0.0162 | 1.336 ± 0.0203 | 1.487 ± 0.0196 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, 4, 6, 8 10, and 12 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Day 1 | 1.566 ± 0.0168 | 1.407 ± 0.0207 | 1.534 ± 0.0206 |
| Week 12 (n=133, 69, 70) | 1.539 ± 0.0261 | 1.398 ± 0.0324 | 1.505 ± 0.0320 |
| Week 52 (n=125, 62, 58) | 1.492 ± 0.0265 | 1.364 ± 0.0352 | 1.424 ± 0.0344 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.
| Liters | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Week 12 | 1.486 ± 0.0236 | 1.380 ± 0.0298 | 1.459 ± 0.0294 |
| Week 52 (n=125, 62, 58) | 1.445 ± 0.0261 | 1.339 ± 0.0346 | 1.379 ± 0.0338 |
The number of moderate or severe exacerbations of COPD per year during the study was calculated by dividing the total number of exacerbations during the study by the total number of years of treatment. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.
| Exacerbations per treatment year | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52) | 0.54 (0.496 to 0.869) | 0.80 (0.586 to 1.105) | 0.62 (0.614 to 1.085) |
A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.
| Percentage of participants | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) | 32.8 | 40.2 | 30.1 |
A night with "no nighttime awakenings" was defined as any night where the patient did not wake up due to 1 or more of 6 symptoms (respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Symptoms occurring during the previous 12 hours were recorded each morning and evening by the patient in an electronic diary. The percentage of nights with 'no nighttime awakenings' was calculated as the total number of nights with "no nighttime awakenings" over the 52 week treatment period divided by the total number of nights where diary recordings were made.
| Percentage of nights | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Percentage of Nights With "no Nighttime Awakenings" During the Study (Baseline to Week 52) | 57.36 ± 1.842 | 52.15 ± 2.239 | 55.47 ± 2.230 |
A day with "no daytime symptoms" was defined as any day where the patient recorded no cough, no wheeze, no production of sputum, no feeling of breathlessness (other than when running), and no puffs of rescue medication during the previous 12 hours in evening entry in the electronic patient diary. The percentage of days with "no daytime symptoms" was calculated as the total number of days with "no daytime symptoms" over the 52 week treatment period divided by the total number of days where diary recordings were made.
| Percentage of days | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Percentage of Days With "no Daytime Symptoms" During the Study (Baseline to Week 52) | 6.54 ± 1.208 | 3.81 ± 1.431 | 7.14 ± 1.424 |
A "day able to perform usual daily activities" was defined as any day where the patient recorded in their electronic diary in the evening that they were not prevented from performing their usual daily activities due to respiratory symptoms during the previous 12 hours. The percentage of "days able to perform usual daily activities" was calculated as the total number of "days able to perform usual daily activities" over the 52 week treatment period divided by the total number of days where diary recordings were made.
| Percentage of days | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Percentage of "Days Able to Perform Usual Daily Activities" During the Study (Baseline to Week 52) | 38.02 ± 1.883 | 36.18 ± 2.270 | 38.09 ± 2.259 |
The daily total symptom score was defined as the sum of the morning and evening patient self-reported diary assessments of 6 symptoms (respiratory symptoms/impact on daily activities, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Means for baseline (14 day maximum run-in period) and the 52 week treatment period were calculated. Mean scores ranged from 0-18, with a higher score indicating worse symptoms. A negative change score indicated improvement.
| Units on a scale | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52) | -1.85 ± 0.125 | -1.42 ± 0.149 | -1.87 ± 0.149 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glycopyrronium Bromide 50 μg | — | 65/525 (12.4%) | 305/525 (58.1%) |
| Placebo to Glycopyrronium Bromide | — | 43/268 (16%) | 164/268 (61.2%) |
| Tiotropium 18 μg | — | 40/267 (15%) | 156/267 (58.4%) |
| Event | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 19/525 | 16/268 | 13/267 |
| PneumoniaInfections and infestations | 7/525 | 7/268 | 4/267 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/525 | 4/268 | 1/267 |
| Non-cardiac chest painGeneral disorders | 1/525 | 0/268 | 3/267 |
| Angina pectorisCardiac disorders | 1/525 | 3/268 | 0/267 |
| Upper respiratory tract infection bacterialInfections and infestations | 2/525 | 3/268 | 2/267 |
| Atrial fibrillationCardiac disorders | 4/525 | 0/268 | 0/267 |
| DehydrationMetabolism and nutrition disorders | 4/525 | 2/268 | 0/267 |
| Intestinal obstructionGastrointestinal disorders | 0/525 | 0/268 | 2/267 |
| Lobar pneumoniaInfections and infestations | 0/525 | 1/268 | 2/267 |
| Event | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg |
|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 180/525 | 106/268 | 85/267 |
| Upper respiratory tract infectionInfections and infestations | 57/525 | 33/268 | 29/267 |
| Upper respiratory tract infection bacterialInfections and infestations | 28/525 | 25/268 | 20/267 |
| NasopharyngitisInfections and infestations | 47/525 | 15/268 | 21/267 |
| Urinary tract infectionInfections and infestations | 14/525 | 8/268 | 16/267 |
| SinusitisInfections and infestations | 28/525 | 14/268 | 9/267 |
| HypertensionVascular disorders | 20/525 | 12/268 | 14/267 |
| HeadacheNervous system disorders | 25/525 | 14/268 | 12/267 |
| Viral upper respiratory tract infectionInfections and infestations | 9/525 | 13/268 | 9/267 |
| Back painMusculoskeletal and connective tissue disorders | 24/525 | 9/268 | 12/267 |
| Age Continuous(years) | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg | Total |
|---|---|---|---|---|
| Mean | 63.5 ± 9.05 | 63.6 ± 9.14 | 63.9 ± 8.25 | 63.6 ± 8.87 |
| Sex: Female, Male(Participants) | Glycopyrronium Bromide 50 μg | Placebo to Glycopyrronium Bromide | Tiotropium 18 μg | Total |
|---|---|---|---|---|
| Female | 186 | 95 | 99 | 380 |
| Male | 339 | 173 | 168 | 680 |
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