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. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística.
- Conditions
- Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of greater than or equal to 35 % and less than or equal to 80 percent of predicted) Bronquiectasias idiopática y post-neumónica no debidas a fibrosis quística en pacientes en situación pulmonar estable (definida como mayor o igual al 35% y menor o igual al 80%)MedDRA version: 9.1 Level: LLT Classification code 10006445 Term: BronchiectasisMedDRA version: 9.1 Level: PT Classification code 10006445 Term: Bronchiectasis
- Registration Number
- EUCTR2009-009869-34-ES
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
· Adults at least 18 years of age
· Pulmonary stable patients with a proven and documented diagnosis of non-CF idiopathic or post pneumonic bronchiectasis by a high-resolution CT scan compatible with bronchiectasis at initial diagnosis and greater than 1 course(s) of systemic antibiotics for exacerbations or greater than or equal to 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 greater than or equal to 35 % and less than or equal to 80 %
· Pre-treatment sputum sample available (patient must be able to produce a sputum sample with a volume greater than or equal to 10 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
·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 (greater than or equal to 300 cm3 or requiring blood transfusion) in the preceding 4 weeks
· Nebulized antibiotics as maintenance therapy within the previous 4 weeks
· Antibiotic treatment of an exacerbation within previous 4 weeks
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