Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939

• Conditions: Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted); MedDRA version: 9.1Level: LLTClassification code 10006445Term: Bronchiectasis; MedDRA version: 9.1Level: PTClassification code 10006445Term: Bronchiectasis

• Registration Number: EUCTR2009-009869-34-SE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

· Adults at least 18 years of age
· Pulmonary stable patients with a proven and documented diagnosis of non-CF idiopathic or post pneumonic bronchiectasis (including patients with primary ciliary dyskinesia) by a CT scan compatible with bronchiectasis at initial diagnosis and > 1 course(s) of systemic antibiotics for exacerbations or = 1 hospitalization for i.v. antibiotic treatment for pulmonary exacerbation during last 12 months.
· Stable pulmonary status, as indicated by a forced expired volume in 1 second (FEV1, percent of predicted) of = 35 % and = 80 %
· Pre-treatment sputum sample available (patient must be able to produce a sputum sample with a volume = 5 mL) that is positive for at least one of the pre-defined pathogens

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

·FEV 1 (percent of predicted) < 35% or > 80% (post bronchodilator)
· Allergic bronchopulmonary aspergillosis (diagnosed radiologically, serologically or clinically)
· Immunodeficiency disease requiring immunoglobulin replacement
· Non-tuberculosis mycobacteria infection
· Rheumatoid arthritis
· Recent significant hemoptysis (= 300 cm3 or requiring blood transfusion) in the preceding 4 weeks
· Nebulized antibiotics as maintenance therapy within the previous 4 weeks prior to randomization
· Antibiotic treatment of an exacerbation or any other infection within previous 4 weeks prior to randomization

Study & Design

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