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Study Name: Inhaled Aztreonam Vs. TOBI in People with CF and P. aeruginosa
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: 200
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study looked at the safety and effectiveness of Aztreonam for Inhalation Solution versus Tobramycin Nebulizer Solution in adult and pediatric cystic fibrosis (CF) patients aged 6 years or older with pulmonary Pseudomonas aeruginosa (PA) infection.
ELIGIBILITY
Age: >= 6 Years
FEV1: 1 - 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.
FOR MORE INFORMATION:
Sponsor Contact Information: Abuan, Tammy
(206) 792-3034
tammy.abuan@gilead.com
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00757237?term=aztreonam+and+cystic+fibrosis&rank=6
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

This International Phase 3 open label 6-month trial evaluated the safety and efficacy of 3 on/off courses of Cayston® (AZLI) vs TOBI® (TNS) in PA infected CF patients (Age >=6). Two-hundred sixty-eight patients received either 75 mg Cayston three times daily or 300 mg TOBI twice daily for 3 cycles of 28 days on/28 days off.
The trial met the co-primary endpoints of non-inferiority of Cayston for mean % change in FEV1 % predicted at Day 28 (Cayston: 8.35%; TOBI: 0.55%; p <0.001) and superiority of Cayston for mean actual change in FEV1% predicted across 3 treatment cycles (Cayston: 2.05%; TOBI: -0.66%; p= 0.002).

Secondary Efficacy:

Cayston also reduced respiratory-related hospitalization and total number of respiratory events requiring intravenous and/or additional inhaled antipseudomonal antibiotics.

Safety:

Safety results were similar across both groups.

Citation:

J Cyst Fibros 2013;12:130-140

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