An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística
- Conditions
- Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA).MedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis
- Registration Number
- EUCTR2007-004277-26-ES
- Lead Sponsor
- Gilead Sciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 274
•Patients with CF who have PA present in an expectorated sputum culture or throat swab at or within 3 months prior to Screening
•Male or female aged 6 years and over
•Patients must have received previous treatment with aerosolized antibiotics without demonstration of drug intolerance
•Changes in azithromycin within 28 days of Screening will be excluded
•Use of inhaled, intravenous (IV) or oral antipseudomonal antibiotics during the 14 days prior to Screening will be excluded
•FEV1 = 75% predicted at Screening
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 corticosteroids in doses exceeding the equivalent of 10 mg 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 supplementation or requirement for more than 2 L/minute at night
•Administration of any investigational drug or device within 28 days of Visit 1 or within 6 half-lives of the investigational drug (whichever is longer)
•Known local or systemic hypersensitivity to monobactam antibiotics
•Known allergies/intolerance to tobramycin
•Inability to tolerate inhalation of a short acting ?2 agonist
•Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1
•Administration of antipseudomonal antibiotics by inhalation, intravenous or oral routes within the 14 days prior to Visit 1
•Changes in antimicrobial, bronchodilator (BD), dornase alfa, or corticosteroid medications within 7 days prior to Visit 1
•Changes in physiotherapy technique or schedule within 7 days prior to Visit 1
•History of lung transplantation
•Abnormal renal or hepatic function or serum chemistry at Visit 1
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