Phase 3
N=934
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease II
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00796653 ↗Enrolled (actual)
934
Serious AEs
17.0%
Results posted
Jun 2014
Primary outcome: Primary: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks — -0.013; 0.116; 0.140; 0.137 Liter — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Olodaterol (BI 1744) (Drug); Formoterol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2010
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 24 Weeks |
-0.013; 0.116; 0.140; 0.137 | <0.0001 sig |
| PRIMARY Trough FEV1 Response at Week 24 |
-0.055; -0.003; 0.014; -0.013 | 0.0055 sig |
| PRIMARY Mahler Transitional Dyspnea Index Focal Score at 24 Weeks |
1.102; 1.504; 1.521; 1.703 | 0.1999 |
| PRIMARY Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis |
1.471; 1.980; 1.996; 1.827 | 0.0270 sig |
| SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks |
42.120; 38.970; 38.597; 40.704 | 0.0197 sig |
| SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks |
39.914; 39.562; 38.824; 40.025 | 0.7995 |
| SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks |
42.679; 40.054; 40.190; 39.521 | 0.0491 sig |
| SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis |
41.639; 38.794; 38.205; 40.391 | 0.0034 sig |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks |
0.021; 0.181; 0.214; 0.183 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks |
-0.010; 0.162; 0.181; 0.174 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks |
-0.008; 0.138; 0.167; 0.163 | <0.0001 sig |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks |
-0.025; 0.093; 0.116; 0.104 | <0.0001 sig |
| SECONDARY Trough FEV1 Response at Week 2 |
-0.016; 0.053; 0.103; 0.033 | 0.0002 sig |
| SECONDARY Trough FEV1 Response at Week 6 |
-0.036; 0.047; 0.068; 0.034 | <0.0001 sig |
| SECONDARY Trough FEV1 Response at Week 12 |
-0.041; 0.018; 0.052; 0.024 | 0.0017 sig |
| SECONDARY Trough FEV1 Response at Week 18 |
-0.036; 0.013; 0.049; 0.015 | 0.0085 sig |
| SECONDARY Trough FEV1 Response at Week 32 |
-0.039; 0.023; 0.034; 0.009 | 0.0012 sig |
| SECONDARY Trough FEV1 Response at Week 40 |
-0.043; 0.019; 0.041; 0.013 | 0.0014 sig |
| SECONDARY Trough FEV1 Response at Week 48 |
-0.060; -0.016; -0.001; -0.024 | 0.0228 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 2 Weeks |
0.099; 0.260; 0.278; 0.253 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 6 Weeks |
0.066; 0.235; 0.248; 0.242 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 12 Weeks |
0.064; 0.206; 0.232; 0.228 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 24 Weeks |
0.060; 0.183; 0.211; 0.203 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 48 Weeks |
0.052; 0.163; 0.178; 0.170 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks |
0.082; 0.312; 0.332; 0.348 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks |
0.027; 0.277; 0.276; 0.307 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks |
0.006; 0.235; 0.253; 0.280 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks |
0.012; 0.212; 0.225; 0.253 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks |
-0.036; 0.182; 0.201; 0.184 | <0.0001 sig |
| SECONDARY Trough FVC Response at Week 2 |
0.030; 0.118; 0.173; 0.111 | 0.0133 sig |
| SECONDARY Trough FVC Response at Week 6 |
-0.014; 0.113; 0.101; 0.085 | 0.0004 sig |
| SECONDARY Trough FVC Response at Week 12 |
-0.041; 0.062; 0.062; 0.070 | 0.0045 sig |
| SECONDARY Trough FVC Response at Week 18 |
-0.014; 0.084; 0.107; 0.064 | 0.0077 sig |
| SECONDARY Trough FVC Response at Week 24 |
-0.044; 0.023; 0.019; -0.005 | 0.0718 |
| SECONDARY Trough FVC Response at Week 32 |
-0.007; 0.081; 0.063; 0.036 | 0.0190 sig |
| SECONDARY Trough FVC Response at Week 40 |
-0.016; 0.071; 0.105; 0.037 | 0.0200 sig |
| SECONDARY Trough FVC Response at Week 48 |
-0.069; 0.012; 0.032; -0.031 | 0.0307 sig |
| SECONDARY Peak FVC (0-3h) Response After 2 Weeks |
0.247; 0.480; 0.476; 0.495 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response After 6 Weeks |
0.196; 0.443; 0.417; 0.450 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response After 12 Weeks |
0.171; 0.386; 0.396; 0.436 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response After 24 Weeks |
0.189; 0.371; 0.369; 0.397 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response After 48 Weeks |
0.137; 0.325; 0.352; 0.329 | <0.0001 sig |
| SECONDARY Peak Expiratory Flow Rate (PEFR) at Week 24 |
196.789; 210.496; 217.660; 211.038; 202.505; 219.905 | 0.0021 sig |
| SECONDARY Use of Rescue Medication at Week 24 |
1.189; 1.036; 0.923; 0.967; 1.713; 1.435 | 0.2057 |
| SECONDARY Patient's Global Rating (PGR) at 6 Weeks |
3.4; 3.1; 3.2; 3.1 | 0.0164 sig |
| SECONDARY Patient's Global Rating (PGR) at 12 Weeks |
3.3; 3.1; 3.0; 3.0 | 0.0388 sig |
| SECONDARY Patient's Global Rating (PGR) at 24 Weeks |
3.3; 3.1; 3.1; 3.1 | 0.0555 |
| SECONDARY Patient's Global Rating (PGR) at 48 Weeks |
3.2; 3.2; 3.0; 3.2 | 0.5707 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 6 Weeks |
0.980; 1.417; 1.686; 1.444 | 0.1524 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 12 Weeks |
1.080; 1.742; 1.747; 1.499 | 0.0319 sig |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 18 Weeks |
1.0454; 1.470; 1.537; 1.579 | 0.1714 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 32 Weeks |
1.168; 1.658; 1.522; 1.477 | 0.1235 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 40 Weeks |
1.064; 1.377; 1.545; 1.178 | 0.3287 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 48 Weeks |
1.113; 1.510; 1.831; 1.280 | 0.2176 |
| SECONDARY Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
173; 177; 252; 270; 252; 234 | 0.1946 |
| SECONDARY Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization |
NA; NA; NA; NA; NA; NA | 0.2942 |
| SECONDARY Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation |
176; 214; 264; 312; 324; 327 | 0.2494 |
| SECONDARY Number of COPD Exacerbations |
0.6890; 0.5409; 0.5947; 0.7325 | 0.1571 |
| SECONDARY Number of COPD Exacerbations Requiring Hospitalization |
0.0986; 0.0781; 0.0993; 0.1025 | 0.5326 |
| SECONDARY Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations |
0.5548; 0.4128; 0.4351; 0.5415 | 0.1136 |
| SECONDARY Changes in Safety Parameters Related to Treatment |
0.9; 0.0; 0.9; 0.0; 0.0; 0.0 | — |
| SECONDARY Absolute Plasma Concentrations |
3.920; 6.977 | — |
Summary
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.
Eligibility Criteria
Inclusion criteria
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1 x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN
- Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
- Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute)
- Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization 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, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse
- Patients who have undergone thoracotomy with pulmonary resection
- Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
- Patients who regularly use daytime oxygen therapy for more than one hour per day.
- 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
- Pregnant or nursing women
- Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
Data sourced from ClinicalTrials.gov (NCT00796653). 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.