Cystic Fibrosis Clinical Trial
Official title:
A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second [FEV1] >75% predicted, and Pseudomonas aeruginosa (PA) infection.
CF patients often have lung infections that occur repeatedly or worsen over time. The lung
infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with
antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given
by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to
evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic
aztreonam and administered three times a day using the PARI eFlow® electronic nebulizer, in
CF patients with PA and mild lung disease.
In this study, participant eligibility was assessed at a screening visit that occurred up to
14 days prior to the baseline visit (Day 0). Those participants who met eligibility criteria
at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI or
placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit
at Day 28, and a follow up visit 14 days after the last dose of the trial drug (Day 42).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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