Phase 3
Completed N=624
12 / 48 Week Pivotal PFT vs PBO in COPD I
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00782210 ↗
Enrolled (actual)
624
Serious AEs
18.6%
Results posted
Apr 2014
Primary outcomePrimary: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) — -0.007; 0.165; 0.169 Liter — p=<0.0001
Summary
This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).
The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) |
-0.007; 0.165; 0.169 | <0.0001 sig |
| PRIMARY Trough FEV1 Response at Day 85 (12 Weeks) |
-0.041; 0.050; 0.060 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks) |
-0.029; 0.144; 0.139 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 1 |
0.024; 0.189; 0.199 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks |
-0.000; 0.180; 0.192 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks |
-0.001; 0.169; 0.165 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks |
-0.18; 0.156; 0.143 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks |
-0.043; 0.130; 0.126 | <0.0001 sig |
| SECONDARY Trough FEV1 Response After 2 Weeks |
-0.019; 0.076; 0.091 | <0.0001 sig |
| SECONDARY Trough FEV1 Response After 6 Weeks |
-0.022; 0.073; 0.069 | <0.0001 sig |
| SECONDARY Trough FEV1 Response After 18 Weeks |
-0.042; 0.056; 0.059 | <0.0001 sig |
| SECONDARY Trough FEV1 Response After 24 Weeks |
-0.050; 0.036; 0.039 | <0.0001 sig |
| SECONDARY Trough FEV1 Response After 32 Weeks |
-0.051; 0.041; 0.034 | <0.0001 sig |
| SECONDARY Trough FEV1 Response After 40 Weeks |
-0.061; 0.046; 0.044 | <0.0001 sig |
| SECONDARY Trough FEV1 Response After 48 Weeks |
-0.74; 0.019; 0.017 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response At Day 1 |
0.104; 0.259; 0.275 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 2 Weeks |
0.077; 0.254; 0.267 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 6 Weeks |
0.066; 0.238; 0.238 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 12 Weeks |
0.071; 0.235; 0.236 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 24 Weeks |
0.055; 0.230; 0.206 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 48 Weeks |
0.029; 0.198; 0.192 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1 |
0.063; 0.350; 0.392 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks |
0.026; 0.323; 0.353 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks |
0.022; 0.276; 0.316 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks |
0.003; 0.277; 0.295 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks |
0.026; 0.261; 0.281 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks |
-0.040; 0.204; 0.231 | <0.0001 sig |
| SECONDARY Trough FVC Response After 2 Weeks |
-0.015; 0.132; 0.169 | <0.0001 sig |
| SECONDARY Trough FVC Response After 6 Weeks |
-0.005; 0.125; 0.135 | 0.0003 sig |
| SECONDARY Trough FVC Response After 12 Weeks |
-0.030; 0.085; 0.130 | 0.0019 sig |
| SECONDARY Trough FVC Response After 18 Weeks |
-0.028; 0.102; 0.134 | 0.0005 sig |
| SECONDARY Trough FVC Response After 24 Weeks |
-0.028; 0.055; 0.096 | 0.0261 sig |
| SECONDARY Trough FVC Response After 32 Weeks |
-0.026; 0.065; 0.097 | 0.0154 sig |
| SECONDARY Trough FVC Response After 40 Weeks |
-0.044; 0.087; 0.111 | 0.0006 sig |
| SECONDARY Trough FVC Response After 48 Weeks |
-0.083; 0.011; 0.032 | 0.0134 sig |
| SECONDARY FVC Peak (0-3h) Response At Day 1 |
0.245; 0.509; 0.546 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 2 Weeks |
0.207; 0.471; 0.499 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 6 Weeks |
0.180; 0.430; 0.460 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 12 Weeks |
0.169; 0.421; 0.430 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 24 Weeks |
0.188; 0.419; 0.420 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 48 Weeks |
0.109; 0.356; 0.369 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks) |
-0.019; 0.283; 0.230 | <0.0001 sig |
| SECONDARY Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF) |
180.019; 193.376; 195.475 | 0.0018 sig |
| SECONDARY Weekly Mean Evening Peak Expiratory Flow Rate (PEF) |
190.676; 207.862; 205.236 | <0.0001 sig |
| SECONDARY Weekly Mean Daytime Rescue Use |
1.487; 0.967; 0.839 | 0.0045 sig |
| SECONDARY Weekly Mean Nighttime Rescue Use |
2.283; 1.701; 1.492 | 0.0041 sig |
| SECONDARY Weekly Mean Daily (24h) Rescue Use |
3.747; 2.642; 2.312 | 0.0019 sig |
| SECONDARY Patient's Global Rating at Week 6 |
3.5; 3.0; 3.0 | <0.0001 sig |
| SECONDARY Patient's Global Rating at Week 12 |
3.4; 3.0; 3.0 | <0.0001 sig |
| SECONDARY Patient's Global Rating at Week 24 |
3.5; 3.0; 3.0 | <0.0001 sig |
| SECONDARY Patient's Global Rating at Week 48 |
3.4; 3.1; 3.1 | 0.0109 sig |
| SECONDARY Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
194.0; 160.0; 203.0; 236.0; 167.0; 239.0 | 0.0658 |
| SECONDARY Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization |
NA; NA; NA; NA; NA; NA | 0.2754 |
| SECONDARY Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
194.0; 216.0; 218.0; 344.0; 170.0; 309.0 | 0.1194 |
| SECONDARY Number of COPD Exacerbations |
0.7476; 0.5842; 0.6322 | 0.1631 |
| SECONDARY Number of COPD Exacerbations Requiring Hospitalization |
0.1010; 0.0662; 0.1133 | 0.2985 |
| SECONDARY Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations |
0.5745; 0.4643; 0.4875 | 0.2911 |
| SECONDARY Changes in Safety Parameters Related to Treatment |
13.4; 2.4; 3.9; 0.0; 0.0; 1.0 | — |
| SECONDARY Change From Baseline in Potassium |
0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion criteria
- All patients must have a diagnosis of chronic obstructive pulmonary disease
- Male or female patients, 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1 <80% predicted and post-bronchodilator FEV1/FVC <70%
Exclusion criteria
- Patients with a significant disease other than COPD
- Patients with a history of asthma
- Patients with any of the following conditions:
a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the past year. known active tuberculosis a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis
Data sourced from ClinicalTrials.gov (NCT00782210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.