Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with P. aeruginosa (AIR-CF1)
Study Type:
Interventional
Intervention Category:
Anti-Infective
Study Sponsor:
Gilead
Study Phase:
3
Recruitment Status:
Trial Completed
Study Drug(s):
Aztreonam Lysine for Inhalation
Number of Participants Being Recruited:
110
Single / Multi-Center:
Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this study is to evaluate the safety and efficacy of an experimental inhaled antibiotic, Aztreonam, in CF patients who have respiratory infections caused by the Pseudomonas aeruginosa bacteria. Reducing damage from chronic Pseudomonas aeruginosa lung infections is vital to maintaining best health in people with CF.
ELIGIBILITY
Age:
>= 6 Years
FEV1:
25 - 75 Percent Predicted
P. aeruginosa status:
Positive
B. cepacia status:
Negative
Other Primary Eligibility Requirements:
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
One hundred and sixty-three patients who were > 6 years of age with moderate to severe lung disease (FEV1 >25% to <75% predicted) were enrolled. The primary outcome measure was change in respiratory symptoms using the CFQ-R Respiratory Score. After 28-days treatment, AZLI improved mean CFQ-R-Respiratory scores(9.7 points, P<0.001) compared with placebo.
Secondary Efficacy:
Pver the 28-day treatment period, AZLI also improved FEV1 (10.3%, P<0.001), and sputum PA density (-1.453 log10CFU/gram, P<0.001) when compared with placebo.
Safety:
Adverse events for AZLI and placebo were comparable except the incidence of “productive cough” was reduced by half in AZLI-treated patients. Adverse events were consistent with symptoms of CF lung disease.
