Phase 3
Completed N=642
12 / 48 wk Pivotal PFT vs PBO in COPD II
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00782509 ↗
Enrolled (actual)
642
Serious AEs
15.7%
Results posted
Jun 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) — 0.008; 0.159; 0.152 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).
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) |
0.008; 0.159; 0.152 | <0.0001 sig |
| PRIMARY Trough FEV1 Response at Day 85 (12 Weeks) |
-0.003; 0.044; 0.045 | 0.0116 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks) |
0.010; 0.120; 0.100 | <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 |
0.025; 0.189; 0.196 | <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 |
0.025; 0.188; 0.177 | <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 |
0.010; 0.180; 0.171 | <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 |
-0.010; 0.155; 0.126 | <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 |
-0.030; 0.132; 0.128 | <0.0001 sig |
| SECONDARY Trough FEV1 Response After 2 Weeks |
0.013; 0.066; 0.078 | 0.0043 sig |
| SECONDARY Trough FEV1 Response After 6 Weeks |
-0.002; 0.071; 0.082 | <0.0001 sig |
| SECONDARY Trough FEV1 Response After 18 Weeks |
-0.007; 0.062; 0.037 | 0.0002 sig |
| SECONDARY Trough FEV1 Response After 24 Weeks |
-0.036; 0.033; 0.022 | 0.0003 sig |
| SECONDARY Trough FEV1 Response After 32 Weeks |
-0.029; 0.029; -0.002 | 0.0024 sig |
| SECONDARY Trough FEV1 Response After 40 Weeks |
-0.029; 0.033; 0.043 | 0.0012 sig |
| SECONDARY Trough FEV1 Response After 48 Weeks |
-0.057; 0.011; 0.014 | 0.0004 sig |
| SECONDARY Peak FEV1 (0-3h) Response At Day 1 |
0.099; 0.267; 0.276 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 2 Weeks |
0.104; 0.259; 0.251 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 6 Weeks |
0.080; 0.252; 0.246 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 12 Weeks |
0.088; 0.232; 0.217 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 24 Weeks |
0.062; 0.226; 0.197 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 48 Weeks |
0.041; 0.197; 0.198 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1 |
0.052; 0.383; 0.384 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks |
0.096; 0.338; 0.323 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks |
0.048; 0.312; 0.294 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks |
0.046; 0.284; 0.291 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks |
0.062; 0.303; 0.281 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks |
0.053; 0.271; 0.271 | <0.0001 sig |
| SECONDARY Trough FVC Response After 2 Weeks |
0.054; 0.113; 0.141 | 0.1040 |
| SECONDARY Trough FVC Response After 6 Weeks |
0.029; 0.122; 0.147 | 0.0106 sig |
| SECONDARY Trough FVC Response After 12 Weeks |
0.043; 0.075; 0.091 | 0.3821 |
| SECONDARY Trough FVC Response After 18 Weeks |
0.064; 0.114; 0.098 | 0.1808 |
| SECONDARY Trough FVC Response After 24 Weeks |
0.021; 0.066; 0.091 | 0.2312 |
| SECONDARY Trough FVC Response After 32 Weeks |
0.061; 0.099; 0.058 | 0.3110 |
| SECONDARY Trough FVC Response After 40 Weeks |
0.062; 0.104; 0.131 | 0.2680 |
| SECONDARY Trough FVC Response After 48 Weeks |
-0.008; 0.038; 0.054 | 0.2249 |
| SECONDARY FVC Peak (0-3h) Response At Day 1 |
0.202; 0.534; 0.535 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 2 Weeks |
0.254; 0.479; 0.464 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 6 Weeks |
0.183; 0.451; 0.434 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 12 Weeks |
0.213; 0.439; 0.422 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 24 Weeks |
0.223; 0.449; 0.429 | <0.0001 sig |
| SECONDARY FVC Peak (0-3h) Response After 48 Weeks |
0.208; 0.415; 0.419 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks) |
0.057; 0.199; 0.212 | 0.0028 sig |
| SECONDARY Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF) |
182.939; 196.300; 203.873 | 0.0072 sig |
| SECONDARY Weekly Mean Evening Peak Expiratory Flow Rate (PEF) |
195.502; 207.958; 216.155 | 0.0169 sig |
| SECONDARY Weekly Mean of Daily Daytime Rescue Use |
1.363; 0.947; 0.850 | 0.0011 sig |
| SECONDARY Weekly Mean of Daily Nighttime Rescue Use |
2.072; 1.652; 1.312 | 0.0077 sig |
| SECONDARY Weekly Mean of Daily (24h) Rescue Use |
3.436; 2.599; 2.158 | 0.0010 sig |
| SECONDARY Patient's Global Rating at Week 6 |
3.3; 3.0; 2.9 | 0.0122 sig |
| SECONDARY Patient's Global Rating at Week 12 |
3.2; 2.9; 3.0 | 0.0028 sig |
| SECONDARY Patient's Global Rating at Week 24 |
3.3; 3.0; 2.9 | 0.0180 sig |
| SECONDARY Patient's Global Rating at Week 48 |
3.3; 3.1; 3.0 | 0.1313 |
| SECONDARY Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
306.0; 259.0; 225.0; 315.0; 219.0; 216.0 | 0.9853 |
| SECONDARY Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization |
NA; NA; NA; NA; NA; NA | 0.9035 |
| SECONDARY Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
NA; 362.0; NA; NA; 225.0; 308.0 | 0.6690 |
| SECONDARY Number of COPD Exacerbations |
0.4590; 0.5453; 0.5885 | 0.3637 |
| SECONDARY Number of COPD Exacerbations Requiring Hospitalization |
0.0786; 0.0811; 0.0886 | 0.9455 |
| SECONDARY Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations |
0.3375; 0.4335; 0.4513 | 0.2514 |
| SECONDARY Changes in Safety Parameters Related to Treatment |
13.9; 3.3; 5.5; 0.0; 0.5; 0.0 | — |
| 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 (NCT00782509). 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.