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Study Name: Long-term Safety Study of Aztreonam Lysinate in CF Patients with P. aeruginosa (AIR-CF3)
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: 370
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this study was to evaluate the safety of an 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 the best health in people with CF. Aztreonam has been successfully used to treat CF lung infections and other diseases in a formulation for intravenous or intramuscular injection.
ELIGIBILITY
Age: >= 6 Years
FEV1: 25 - 75 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

To be included in this open-label extension study, a subject must have completed either Air-CF1 or Air-CF2.
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:
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00128492?term=gilead+and+cystic+fibrosis&rank=8
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

This open-label study included 274 patients with CF (Age >=6) with pulmonary P. aeruginosa and who had completed one of two previous double-blind studies (AIR CF 1 or AIR CF 2). Patients received AZLI either twice daily or three times daily for nine cycles of 28 days on-drug followed by 28 days off drug. Patients who received AZLI three times a day had greater improvement in FEV1 and in patient reported outcomes (Cystic Fibrosis Questionnaire รข?? Revised).

Secondary Efficacy:

Median time to hospitalization was also longer in patients treated three times daily compared with patients dosed twice daily.

Safety:

The most common adverse events were those related to respiratory conditions consistent with CF. The two most commonly reported AEs were cough and productive cough. AEs were more frequently reported during the off-drug periods than during the on-drug periods. There was no evidence that the incidence of any common AE increased with repeated exposure.

Citation:

Pediatr Pulmonol 2010;45(11):1121-34

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