Patients with Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Tiotropium 1.25µg/Olodaterol 2.5µg
Product Code: Ba 679/BI 1744
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: tiotropium
Concentration unit: µg microgram(s)
Concentration
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. 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=65 years) yes F.1.3.1 Number of subjects for this age range 76
Exclusion criteria
Exclusion criteria: 1. Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient’s ability to participate in the study. 2. Patients with a, in the opinion of the investigator, clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients). 3. Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count =600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. Patients with any of the following conditions: 4. A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists). 5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists). 6. A history of myocardial infarction within 1 year of screening visit (Visit 1). 7. Unstable or life-threatening cardiac arrhythmia. 8. Hospitalization for heart failure within the past year. 9. Known active tuberculosis. 10. A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed). 11. A history of life-threatening pulmonary obstruction 12. A history of cystic fibrosis. 13. Clinically evident bronchiectasis. 14. A history of significant alcohol or drug abuse. 15. Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1). 16. Patients being treated with oral or patch ß-adrenergics. 17. Patients being treated with 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. 18. 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. 19. 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. 20. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1). 21. Patients with known hypersensitivity to ß-adrenergic drugs, BAC, EDTA, or any other component of the RESPIMAT inhalation solution. 22. Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment.;Secondary Objective: - to compare the 24-hour FEV1-time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg) administered once daily by the RESPIMAT Inhaler with the profile of tiotropium (2.5 µg, 5 µg) and olodaterol (5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment - to determine the 24-hour profile of other lung function parameters (FVC, FRC, IC, TLC, RV) for tiotropium + olodaterol FDC (2.5/5 µg and 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment and compare with the profiles of tiotropium (2.5 µg, 5 µg) and olodaterol (5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment - to assess the pharmacokinetic profiles of tiotropium and olodaterol after administration of tiotropium + olodaterol (2.5/5 µg) FDC and tiotropium + olodaterol (5/5 µg) FDC in COPD patients ;Primary end point(s): FEV1 AUC0-24h response [L];Timepoint(s) of evaluation of this end point: after 6-weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: FEV1 AUC0-12h response [L] FEV1 AUC12-24h response [L] Secondary endpoints Trough FEV1 response [L] Peak FEV1 responses [L] Trough FVC response [L] Peak FVC response [L] FVC AUC0-24h response [L] FVC AUC0-12h response [L] FVC AUC12-24h response [L] ;Timepoint(s) of evaluation of this end point: after 6-weeks treatment | — |
Countries
Belgium, Canada, Denmark, Germany, Hungary, Mexico, Netherlands, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed