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Clinical Trial Finder
Anti-Infective Completed with Results
Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with Mild Lung Disease and P. aeruginosa (AIR-CF4) (GS-US-205-0117)
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
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Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
75% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
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Primary Findings:
Effectiveness:
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 –Revised Respiratory Symptoms Scale was not met (3.22 vs 1.41, AZLI vs placebo-treated patients, respectively).
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).
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Citation:
J Cyst Fibros 2011;10:234-242
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
56 days -
Number of Study Visits:
5
Additional Information
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Phase: ?more info
Phase Three -
Study Sponsor: ?more info
Gilead -
Study Drugs:
Eligibility
-
Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
75% or greater -
Pseudomonas Status:
Positive Respiratory Cultures Required
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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