Phase 2
Completed N=405
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.
Pulmonary Disease, Chronic Obstructive · Asthma
Source: ClinicalTrials.gov NCT00452400 ↗
Enrolled (actual)
405
Serious AEs
2.0%
Results posted
Jun 2014
Primary outcomePrimary: Trough FEV1 Response After 4 Weeks — -0.014; 0.046; 0.082; 0.109 Liter — p=0.0233
Summary
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough FEV1 Response After 4 Weeks |
-0.014; 0.046; 0.082; 0.109; 0.118 | 0.0233 sig |
| SECONDARY Trough FEV1 Response After 1 Week |
-0.029; 0.059; 0.108; 0.099; 0.140 | 0.0004 sig |
| SECONDARY Trough FEV1 Response After 2 Weeks |
-0.023; 0.062; 0.099; 0.102; 0.105 | 0.0011 sig |
| SECONDARY Trough FVC Response After 1 Week |
-0.020; 0.090; 0.154; 0.149; 0.151 | 0.0127 sig |
| SECONDARY Trough FVC Response After 2 Weeks |
-0.000; 0.090; 0.171; 0.149; 0.148 | 0.0836 |
| SECONDARY Trough FVC Response After 4 Weeks |
-0.026; 0.068; 0.136; 0.146; 0.153 | 0.0695 |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4 |
0.013; 0.154; 0.175; 0.226; 0.228 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 4 Weeks |
0.078; 0.242; 0.247; 0.295; 0.303 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4 |
0.009; 0.271; 0.292; 0.320; 0.313 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response After 4 Weeks |
0.152; 0.440; 0.432; 0.449; 0.438 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1 |
0.031; 0.165; 0.203; 0.236; 0.234 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1 |
-0.000; 0.186; 0.215; 0.218; 0.247 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2 |
0.006; 0.166; 0.200; 0.209; 0.211 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response At Day 1 |
0.104; 0.259; 0.288; 0.335; 0.335 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 1 Weeks |
0.062; 0.264; 0.293; 0.295; 0.321 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 2 Weeks |
0.079; 0.243; 0.267; 0.282; 0.280 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response at Day 1 |
0.019; 0.064; 0.166; 0.195; 0.171 | 0.2392 |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 1 Week |
-0.018; 0.067; 0.156; 0.132; 0.118 | 0.0309 sig |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 2 Weeks |
0.006; 0.059; 0.135; 0.105; 0.098 | 0.2150 |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks |
0.005; 0.058; 0.134; 0.145; 0.094 | 0.2158 |
| SECONDARY Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks |
212.69; 226.39; 233.97; 250.77; 235.75 | 0.0211 sig |
| SECONDARY Weekly Mean Evening PEFR After 4 Weeks |
224.65; 235.09; 246.98; 262.88; 250.06 | 0.0973 |
| SECONDARY Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks |
2.914; 2.393; 3.052; 1.949; 2.500 | 0.1541 |
| SECONDARY Area Under Curve From 0 to 3 Hours (AUC0-3) |
13.3; 20.3; 11.6; 21.1 | — |
| SECONDARY Maximum Concentration (Cmax) |
3.58; 5.45; 12.2; 3.94; 5.24; 10.6 | — |
| SECONDARY Time From Dosing to the Maximum Concentration (Tmax) |
0.167; 0.183; 0.200; 2.95; 3.00; 3.00 | — |
| SECONDARY Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss) |
NA; 15.6; 27.7; 9.29; 11.4; 23.9 | — |
| SECONDARY Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss) |
NA; 29.7; 46.4; 21.4; 25.6; 49.4 | — |
| SECONDARY Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss) |
104; 145; NA; NA | — |
| SECONDARY Maximum Concentration at Steady State (Cmax,ss) |
4.02; 7.13; 14.1; 4.90; 5.55; 11.1 | — |
| SECONDARY Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) |
0.192; 0.200; 0.200; 3.00; 3.00; 3.00 | — |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination |
0; 1; 1; 0; 2; 0 | — |
| SECONDARY Laboratory Testing: Average Change From Baseline of Potassium |
0.97; 0.99; 0.98; 0.97; 0.98 | — |
Eligibility Criteria
Inclusion Criteria
- All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with a post-bronchodilator FEV1  30% of predicted normal and 100 beats per minute)
- a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval > 450 ms).
- a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
- Patients with any of the following conditions:
- a history of myocardial infarction within 1 year of screening visit (Visit 1)
- a diagnosis of clinically relevant cardiac arrhythmia
- 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
- clinically evident bronchiectasis
- a history of significant alcohol or drug abuse
- Patients who have undergone thoracotomy with pulmonary resection
- Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- Pregnant or nursing women
- Women of childbearing potential not using a highly effective method of birth control
- Patients who have previously been randomized in this study or are currently participating in another study
- Patients who are unable to comply with medication restrictions.
Data sourced from ClinicalTrials.gov (NCT00452400). 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.