Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis CF PA Pseudomonas aeruginosa AZLI aztreonam
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 105
Healthy volunteers: no

Brief summary:
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA.

The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).

Detailed description:

Arms:
arm 1: Participants will receive one 28-day course of AZLI, then will be followed for a 24-week period (through Day 196).

Interventions: intervention 1: Aztreonam for Inhalation Solution (AZLI)
Intervention descriptions: intervention 1: AZLI 75 mg administered 3 times daily via the investigational eFlow® nebulizer

Protocol document: