Phase 3
N=904
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00793624 ↗Enrolled (actual)
904
Serious AEs
13.6%
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 — -0.009; 0.142; 0.156; 0.168 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 |
-0.009; 0.142; 0.156; 0.168 | <0.0001 sig |
| PRIMARY Trough FEV1 Response at Week 24 |
-0.056; 0.021; 0.028; -0.002 | 0.0002 sig |
| PRIMARY Mahler Transitional Dyspnea Index Focal Score at 24 Weeks |
2.046; 2.234; 2.068; 1.818 | 0.5843 |
| 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 |
41.068; 38.627; 37.674; 40.116 | 0.0816 |
| SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks |
42.105; 39.320; 36.961; 40.351 | 0.0450 sig |
| SECONDARY Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks |
40.415; 38.545; 36.850; 40.431 | 0.1878 |
| 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 |
0.015; 0.201; 0.181; 0.221 | <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 |
0.001; 0.178; 0.161; 0.194 | <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 |
-0.003; 0.176; 0.167; 0.182 | <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 |
-0.023; 0.122; 0.123; 0.149 | <0.0001 sig |
| SECONDARY Trough FEV1 Response at Week 2 |
-0.019; 0.068; 0.060; 0.061 | <0.0001 sig |
| SECONDARY Trough FEV1 Response at Week 6 |
-0.037; 0.049; 0.041; 0.042 | <0.0001 sig |
| SECONDARY Trough FEV1 Response at Week 12 |
-0.027; 0.056; 0.048; 0.033 | <0.0001 sig |
| SECONDARY Trough FEV1 Response at Week 18 |
-0.019; 0.046; 0.026; 0.023 | 0.0016 sig |
| SECONDARY Trough FEV1 Response at Week 32 |
-0.023; 0.023; 0.026; 0.021 | 0.0237 sig |
| SECONDARY Trough FEV1 Response at Week 40 |
-0.020; 0.020; 0.017; 0.004 | 0.0537 |
| SECONDARY Trough FEV1 Response at Week 48 |
-0.065; 0.003; -0.009; -0.006 | 0.0011 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 2 Weeks |
0.100; 0.277; 0.250; 0.290 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 6 Weeks |
0.081; 0.248; 0.234; 0.264 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 12 Weeks |
0.082; 0.247; 0.241; 0.256 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 24 Weeks |
0.068; 0.216; 0.225; 0.236 | <0.0001 sig |
| SECONDARY Peak FEV1 (0-3h) Response After 48 Weeks |
0.053; 0.192; 0.193; 0.215 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks |
0.076; 0.299; 0.311; 0.383 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks |
0.016; 0.252; 0.265; 0.326 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks |
0.023; 0.233; 0.278; 0.300 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks |
0.037; 0.220; 0.252; 0.279 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks |
0.016; 0.196; 0.219; 0.260 | <0.0001 sig |
| SECONDARY Trough FVC Response at Week 2 |
0.042; 0.110; 0.119; 0.126 | 0.0781 |
| SECONDARY Trough FVC Response at Week 6 |
-0.046; 0.065; 0.085; 0.090 | 0.0043 sig |
| SECONDARY Trough FVC Response at Week 12 |
-0.018; 0.079; 0.087; 0.068 | 0.0136 sig |
| SECONDARY Trough FVC Response at Week 18 |
0.060; 0.066; 0.078; 0.063 | 0.8674 |
| SECONDARY Trough FVC Response at Week 24 |
-0.018; 0.038; 0.064; 0.001 | 0.1603 |
| SECONDARY Trough FVC Response at Week 32 |
0.019; 0.080; 0.084; 0.077 | 0.1270 |
| SECONDARY Trough FVC Response at Week 48 |
-0.061; 0.022; -0.002; 0.006 | 0.0385 sig |
| SECONDARY Trough FVC Response at Week 40 |
0.028; 0.087; 0.086; 0.052 | 0.1394 |
| SECONDARY Peak FVC (0-3h) Response After 2 Weeks |
0.268; 0.454; 0.474; 0.551 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response After 6 Weeks |
0.202; 0.411; 0.433; 0.467 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response After 12 Weeks |
0.194; 0.382; 0.432; 0.450 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response After 24 Weeks |
0.207; 0.379; 0.414; 0.424 | <0.0001 sig |
| SECONDARY Peak FVC (0-3h) Response After 48 Weeks |
0.193; 0.344; 0.371; 0.416 | 0.0003 sig |
| SECONDARY Peak Expiratory Flow Rate (PEFR) at Week 24 |
196.429; 211.496; 211.428; 214.070; 202.256; 219.977 | 0.0012 sig |
| SECONDARY Use of Rescue Medication at Week 24 |
1.364; 0.961; 1.037; 1.217; 2.051; 1.449 | 0.0026 sig |
| SECONDARY Patient's Global Rating (PGR) at 6 Weeks |
3.4; 3.0; 3.1; 3.1 | 0.0003 sig |
| SECONDARY Patient's Global Rating (PGR) at 12 Weeks |
3.3; 3.0; 2.9; 3.0 | 0.0021 sig |
| SECONDARY Patient's Global Rating (PGR) at 24 Weeks |
3.1; 2.9; 2.9; 3.0 | 0.0320 sig |
| SECONDARY Patient's Global Rating (PGR) at 48 Weeks |
3.1; 3.0; 2.9; 2.9 | 0.4105 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 6 Weeks |
0.995; 1.566; 1.660; 1.753 | 0.0882 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 12 Weeks |
1.412; 1.792; 1.955; 1.805 | 0.2625 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 18 Weeks |
1.665; 1.897; 2.099; 1.689 | 0.4895 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 32 Weeks |
1.732; 1.898; 1.698; 1.966 | 0.6309 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 40 Weeks |
1.952; 1.839; 1.887; 1.575 | 0.7459 |
| SECONDARY Mahler Transitional Dyspnea Index Focal Score at 48 Weeks |
1.940; 2.035; 2.324; 2.047 | 0.7850 |
| SECONDARY Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
143; 268; 136; 189; 134; 209 | 0.3424 |
| SECONDARY Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization |
NA; NA; NA; NA; NA; NA | 0.1910 |
| SECONDARY Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation |
150; 296; 239; 244; 175; 302 | 0.5577 |
| SECONDARY Number of COPD Exacerbations |
0.5684; 0.7117; 0.6946; 0.5098 | 0.1729 |
| SECONDARY Number of COPD Exacerbations Requiring Hospitalization |
0.0554; 0.1043; 0.1324; 0.0570 | 0.2508 |
| SECONDARY Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations |
0.4765; 0.5537; 0.5114; 0.3721 | 0.4002 |
| SECONDARY Absolute Plasma Concentrations |
4.179; 7.246 | — |
| SECONDARY Changes in Safety Parameters Related to Treatment |
0.4; 0.0; 0.0; 0.9; 0.0; 0.4 | — |
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 (NCT00793624). 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.