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Study Name: Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with Mild Lung Disease and P. aeruginosa (AIR-CF4)
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Gilead
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Cayston
Number of Participants Being Recruited: 140
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study looked at the safety and use of a 28-day treatment with an experimental inhaled antibiotic, aztreonam lysine, (AZLI), in CF patients with mild lung disease and a sputum or throat culture positive for Pseudomonas aeruginosa. Aztreonam in a formulation for intravenous or intramuscular has been successfully used to treat CF lung infections. This new formulation is as an inhaled medication. The study looked to see if after 28 days of treatment there is a change from a person's usual or baseline respiratory symptoms. Study participants were asked to complete a cystic fibrosis questionnaire-revised (CFQ-R) during the study.
ELIGIBILITY
Age: >= 6 Years
FEV1: >= 75 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Not applicable
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.
FOR MORE INFORMATION:
Sponsor Contact Information: Abuan, Tammy
(206) 792-3034
tammy.abuan@gilead.com
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00712166?term=GS-US-205-0117+and+cystic+fibrosis&rank=1
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

This multinational, randomized trial enrolled 160 patients (= 6years) with Pa airway infection and mild impairment of lung function (FEV1 > 75% predicted) at 40 CF centers in the U.S., Canada, and Australia. The study compared AZLI (Cayston®) and placebo administered 3 times daily for 28 days. The primary efficacy endpoint, change from baseline at Day 28 on the CFQ-R RSS (CF Questionnaire â??Revised Respiratory Symptoms Scale was not met (3.22 vs 1.41, AZLI vs placebo-treated patients, respectively).

Secondary Efficacy:

Statistically significant Cayston treatment effects in FEV1 improvements and bacterial density reductions were observed.

Safety:

Cayston® was well tolerated with most adverse events reported as mild to moderate in severity. The most commonly reported adverse events were associated with respiratory symptoms (cough, productive cough).

Citation:

J Cyst Fibros 2011;10:234-242

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