Characterization of lung function profile of inhaled tiotropium + olodaterol fixed dose combination compared to fluticason propionate + salmeterol fixed dose combination in COPD patients
- Conditions
- Chronic Obstructive Pulmonary DiseaseMedDRA version: 16.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-000808-41-SE
- Lead Sponsor
- Boehringer Ingelheim AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 308
1. Diagnosis of chronic obstructive pulmonary disease
2. Relatively stable airway obstruction with a post-bronchodilator 30% 3. Male or female patients, 40 years of age or older
4. Smoking history of more than 10 pack years
5. Ability to perform technically acceptable pulmonary function tests and maintain records
6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 114
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 114
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>;Timepoint(s) of evaluation of this end point: 1: Baseline and 6 weeks<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1: FEV1 AUC0-24h - change from baseline 6-weeks of treatment.<br><br>2: Trough FEV1- change from baseline 6-weeks of treatment.<br><br>3: FEV1 AUC 12-24 h - change from baseline 6-weeks of treatment.<br><br>4: Peak 0-3h FEV1- change from baseline 6-weeks of treatment.<br><br><br><br><br><br>;Timepoint(s) of evaluation of this end point: 1: Baseline and 6 weeks<br><br>2: Baseline and 6 weeks<br><br>3: Baseline and 6 weeks<br><br>4: Baseline and 6 weeks<br><br><br><br><br><br>