Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1 Level: LLT Classification code 10006445 Term: Bronchiectasis MedDRA version: 9.1 Level: PT Classification code 10006445 Term: Bronchiectasis
Conditions
Interventions
Product Name: Cipro Inhale
Product Code: BAYq3939
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Ciprofloxacin
CAS Number: 85721-33-1
Current Sponsor code: BAYQ3939
Concentr
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 dyskenisia) 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
Exclusion criteria: ·FEV 1 (percent of predicted) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study in patients with non-CF bronchiectasis with positive sputum culture is to determine the effect of ciprofloxacin inhale on bacterial density, measured by decadic logarithm (log10) of reduction in colony forming units (CFUs) per gram sputum.;Secondary Objective: - To evaluate the emergence of new potential respiratory pathogens, and the emergence of resistance among baseline pathogens in those patients with persistent infection or colonization - To determine the efficacy and safety of ciprofloxacin inhale - To determine plasma and sputum concentrations of ciprofloxacin at predefined time windows at 2 specific visits during treatment from selected patients in selected centers. ;Primary end point(s): The change from baseline in total bacterial load in the sputum (specified pathogens only) until the end of treatment (4 weeks). Statistically, the main efficacy analysis will be a two-way analysis of covariance (ANCOVA) with factors treatment group (Cipro Inhale, placebo) and center. The dependent variable will be log10(CFU+1) at the end of the 4 week treatment period; baseline log10(CFU+1) will serve as a covariate. | — |
Countries
Germany, Spain, Sweden, United Kingdom
Outcome results
None listed