Chronic Obstructive Pulmonary Disease MedDRA version: 16.0 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 vapour, solution
INN or Proposed INN: TIOTROPIUM
Other descriptive name: TIOTROPIUM
Concen
Sponsors
Boehringer Ingelheim España, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of chronic obstructive pulmonary disease 2. Relatively stable airway obstruction with a post-bronchodilator 30% =65 years) yes F.1.3.1 Number of subjects for this age range 114
Exclusion criteria
Exclusion criteria: 1. Significant disease other than COPD 2. COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months. 3. Clinically relevant abnormal lab values 4. History of asthma 5. Diagnosis of thyrotoxicosis 6. Diagnosis of paroxysmal tachycardia 7.History of myocardial infarction 8. Unstable or life-threatening cardiac arrhythmia 9. Hospitalization for heart failure within the past year 10. Known active tuberculosis 11. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 12. History of life-threatening pulmonary obstruction 13.History of cystic fibrosis 14. Clinically evident bronchiectasis 15.History of significant alcohol or drug abuse 16. History of thoracotomy with pulmonary resection 17. oral or patch ß-adrenergics 18. Oral corticosteroid medication within 6 weeks prior to Visit 1 19. Regular use daytime oxygen therapy for more than one hour per day 20. Pulmonary rehabilitation program in the six weeks prior to the screening visit 21. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit 22. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA 23. Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the trial is to compare the lung function profile of 2 doses of once daily treatment with tiotropium+olodaterol FDC delivered by the RESPIMAT with the lung function profile of 2 doses of twice daily treatment with fluticasone propionate+salmeterol FDC delivered by the Acuhaler® after 6 weeks of treatment.;Secondary Objective: None;Primary end point(s): 1: FEV1 AUC0-12h - change from baseline after 6 weeks of treatment;Timepoint(s) of evaluation of this end point: 1: Baseline and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: FEV1 AUC0-24h - change from baseline 6-weeks of treatment. 2: Trough FEV1- change from baseline 6-weeks of treatment. 3: FEV1 AUC 12-24 h - change from baseline 6-weeks of treatment. 4: Peak 0-3h FEV1- change from baseline 6-weeks of treatment.;Timepoint(s) of evaluation of this end point: 1: Baseline and 6 weeks 2: Baseline and 6 weeks 3: Baseline and 6 weeks 4: Baseline and 6 weeks | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Netherlands, Spain, Sweden
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed