Phase 2
Completed N=360
Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00696020 ↗
Enrolled (actual)
360
Serious AEs
1.7%
Results posted
Aug 2015
Primary outcomePrimary: Trough FEV1 Response [L] After 4 Weeks of Treatment — 0.110; 0.134; 0.143; 0.168 L — p=0.3791
Summary
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough FEV1 Response [L] After 4 Weeks of Treatment |
0.110; 0.134; 0.143; 0.168 | 0.3791 |
| SECONDARY Trough FEV1 Response [L] After 1 and 2 Weeks of Treatment. |
0.093; 0.149; 0.154; 0.166; 0.099; 0.141 | 0.1163 |
| SECONDARY Trough FVC Response [L] After 1, 2 and 4 Weeks of Treatment |
0.156; 0.215; 0.265; 0.275; 0.171; 0.196 | 0.9573 |
| SECONDARY FEV1 AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment |
0.161; 0.201; 0.229; 0.225; 0.204; 0.289 | 0.0052 sig |
| SECONDARY FVC AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment. |
0.268; 0.331; 0.413; 0.410; 0.310; 0.441 | 0.0384 sig |
| SECONDARY PEF AUC(0-3h) Response [L/Min] After First Administration and After 1, 2 and 4 Weeks of Treatment. |
21.973; 35.738; 35.350; 40.027; 29.701; 52.816 | 0.0010 sig |
| SECONDARY FEV1 AUC(0-6h) Response [L] After 4 Weeks of Treatment |
0.194; 0.282; 0.280; 0.322 | 0.0048 sig |
| SECONDARY FVC AUC(0-6h) Response [L] After 4 Weeks of Treatment |
0.309; 0.429; 0.492; 0.547 | 0.0332 sig |
| SECONDARY PEF AUC(0-6h) Response [L] After 4 Weeks of Treatment |
30.576; 53.443; 50.319; 58.368 | 0.0009 sig |
| SECONDARY FEV1 Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment |
0.249; 0.284; 0.311; 0.321; 0.276; 0.359 | 0.0079 sig |
| SECONDARY FVC Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment |
0.428; 0.476; 0.576; 0.583; 0.437; 0.560 | 0.0296 sig |
| SECONDARY PEF Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment |
43.051; 53.801; 53.853; 62.360; 47.819; 69.792 | 0.0010 sig |
| SECONDARY FEV1 and PEF (Unsupervised) AUC(0-6h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment |
— | — |
| SECONDARY FEV1 (Unsupervised) AUC(6-12h) Response [L] After First Administration and 1,2 and 4 Weeks of Treatment |
0.143; 0.181; 0.209; 0.175; 0.169; 0.203 | 0.3517 |
| SECONDARY PEF (Unsupervised) AUC(6-12h) Response [L/Min] After First Administration and 1,2 and 4 Weeks of Treatment |
29.261; 41.838; 45.179; 41.852; 30.139; 47.625 | 0.0899 |
| SECONDARY Weekly Mean Pre-dose Morning PEF [L/Min] |
227.81; 244.43; 248.84; 248.76; 228.57; 240.87 | — |
| SECONDARY Weekly Mean Evening PEF [L/Min] |
249.10; 260.86; 267.47; 268.58; 247.10; 260.73 | — |
| SECONDARY Weekly Mean Number of Occasions of Rescue Therapy Used Per Day |
1.905; 1.512; 1.504; 1.669; 1.784; 1.610 | — |
| SECONDARY Physician's Global Evaluation |
5.139; 5.102; 5.185; 5.149; 5.272; 5.130 | — |
| SECONDARY Patient's Global Rating |
2.866; 2.598; 2.368; 2.377 | — |
| SECONDARY Clinically Significant Anormalities (Laboratory Data); Marked Changes From Baseline for Vital Signs, Notable Change in ECG and New Onset of ECG Abnormalities |
1; 0; 0; 0 | — |
| SECONDARY Cmax,ss Olodaterol [pg/mL] |
4.39; 6.87 | — |
| SECONDARY Tmax,ss Olodaterol [h] |
0.167; 0.183 | — |
| SECONDARY AUC(0-1h,ss) Olodaterol [pg*h/mL] |
3.97; 5.82 | — |
| SECONDARY Cmax,ss Tiotropium [pg/mL] |
13.3; 13.9; 12.4; 14.4 | — |
| SECONDARY Tmax,ss Tiotropium [h] |
0.133; 0.100; 0.083; 0.133 | — |
| SECONDARY AUC(0-3h,ss) Tiotropium [pg*h/mL] |
21.8; 21.9; 21.9; 21.0 | — |
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 airway obstruction with a post-bronchodilator FEV1 greater or equal 30% of predicted normal and = 600/mm3.
- Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF* 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, 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.
- Pregnant or nursing women
- Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
- Patients who have previously been randomized in this study or are currently participating in another study
- Patients who are unable to comply with pulmonary medication restrictions prior to randomization
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit
Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT00696020). 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.