Cystic Fibrosis Clinical Trial
Official title:
Phase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects With Cystic Fibrosis (CF) and Chronic Burkholderia Species Infection
The purpose of this research study was to determine if an experimental drug called Aztreonam
for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections
in patients with cystic fibrosis (CF).
Spirometry was used to assess pulmonary function, and the revised Cystic Fibrosis
Questionnaire (CFQ-R) was used to assess quality of life. The CFQ-R is a validated,
patient-reported outcome tool used to measure health-related quality of life for children
and adults with CF.
The study consisted of a 24-week randomized phase, and a 24-week open-label phase. Primary
and secondary efficacy analyses were conducted for the 24-week randomized phase only. Safety
data were collected for both the randomized and open-label phases.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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