Characterization of lung function profile of inhaled tiotropium + olodaterol fixed dose combination compared to fluticason propionate + salmeterol fixed dose combination in COPD patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 308

Inclusion Criteria

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

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
24. Women of childbearing potential not using a highly effective method of birth control. 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.
25. Patients who have previously been randomized in this study or are currently participating in another study.
26. Patients who are unable to comply with pulmonary medication restrictions prior to randomization.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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