Conditions: Cystic Fibrosis
Keywords: cystic fibrosis Pseudomonas aeruginosa
Allocation: NON_RANDOMIZED | Intervention model: 
Enrollment: 274
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

Detailed description:
People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by PA. Treatment with antibiotics is used to reduce the presence of the bacteria. The antibiotics may be given orally, intravenously, or inhaled as a mist. The purpose of this study was to evaluate whether AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA.

A course of AZLI treatment in this study comprised 28 days, followed by a 28-day period off treatment. Participants could receive up to 9 courses of AZLI, with a total time on study of up to 18 months. Safety and efficacy results for the 18-month, 9-course period are reported, with efficacy results presented on a by-treatment course basis.

Arms:

Interventions: intervention 1: AZLI 75 mg two times a day (BID)/ three times a day (TID)
Intervention descriptions: intervention 1: None

Protocol document: