A Randomised, Phase II, Double-Blind, Double-Dummy, four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 µg bid, MDI), Ciclesonide (400 µg qd, MDI), Ciclesonide (800 µg qd, MDI) or placebo in Free Combination with Open-Label Tiotropium (18 µg qd, HandiHaler®) and Salmeterol (50 µg bid, Diskus®) in Patients with COPD.

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 9.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary disease

• Registration Number: EUCTR2007-003169-42-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Outpatients of either sex, aged = 40 years with a diagnosis of relatively stable, moderate to severe COPD [post bronchodilator 30%= FEV1<80% of predicted (ECSC criteria) and FEV1/FVC <70%] and with a smoking history of more than 10 pack years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Recent history of MI.
2. Hospitalization for heart failure (NYHA class III or IV) within the past year.
3. Unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring an intervention or a change in drug therapy during the past year.
4. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
5. History of asthma, allergic rhinitis or who have a total blood eosinophil count = 600 mm3.
6. History of life-threatening pulmonary obstruction or a history of cystic fibrosis or clinically evident bronchiectasis.
7. Active tuberculosis.
8. Thoracotomy with pulmonary resection.
9. Use of daytime oxygen
10. Resent treatment with theophylline, oral betaadrenergics or systemic corticosteroids at unstable doses
11. Pregnant or nursing women or women of childbearing potential who are not practicing acceptable means of birth control

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified