An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND
- Conditions
- Cystic fibrosisMedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis
- Registration Number
- EUCTR2007-004277-26-IT
- Lead Sponsor
- Gilead Sciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Patient with Cystic Fibrosis(CF) who have pseudomonas aeruginosa present in an expectorated sputum culture or throat swb at or within 3 months before screening. Male or female aged more or 6.
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range
-Current use of oral coticosteroids in doses exceeding the equivalent of 10mg prednisone a day or 20 mg prednisone every other day History of sputum or throat swab culture yielding B. cepacia in the previous 2 years - Current requirement for daily continuous oxygen supplemntation or requirement for more than 2 l/minute at night
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