Phase 3
Completed N=122
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01040728 ↗
Enrolled (actual)
122
Serious AEs
4.0%
Results posted
Jun 2014
Primary outcomePrimary: FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment — -0.008; 0.189; 0.213; 0.213 Liter — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment |
-0.008; 0.189; 0.213; 0.213 | <0.0001 sig |
| PRIMARY FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment |
-0.059; 0.094; 0.111; 0.105 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment |
-0.033; 0.142; 0.158; 0.159 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment |
0.018; 0.232; 0.256; 0.169 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment |
0.011; 0.225; 0.255; 0.246 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response |
0.082; 0.290; 0.325; 0.325 | <0.0001 sig |
| SECONDARY Trough FEV1 Response |
0.003; 0.137; 0.146; 0.161 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response |
-0.006; 0.324; 0.321; 0.364 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response |
-0.109; 0.169; 0.155; 0.192 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response |
-0.057; 0.247; 0.226; 0.278 | <0.0001 sig |
| SECONDARY FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response |
0.044; 0.388; 0.397; 0.414 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response |
0.191; 0.526; 0.537; 0.569 | <0.0001 sig |
| SECONDARY Trough FVC Response |
-0.001; 0.243; 0.215; 0.255 | <0.0001 sig |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG |
1; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
- Patients willing to participate with confirmed diagnosis of COPD
- 40 years of age or older
- having a 10 pack year smoking history
- able to perform serial pulmonary function tests
- able to use both a Dry powder inhaler (DPI) and Respimat device
Exclusion criteria
- Significant other disease
- clinically relevant abnormal hematology, chemistry, or urinalysis
- history of asthma
- diagnosis of thyrotoxicosis
- paroxysmal tachycardia related to beta agonists
- history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
- active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
- significant alcohol or drug abuse
- pulmonary resection
- taking oral beta adrenergics
- taking unstable oral steroids
- daytime oxygen
- enrolled in rehabilitation program
- enrolled in another study or taking investigational products
- pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
- those who are not willing to comply with pulmonary medication washouts
Data sourced from ClinicalTrials.gov (NCT01040728). 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.