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Study Name: Aztreonam Lysinate for Inhalation in Individuals who Utilize Inhaled Tobramycin Frequently (AIR-CF2)
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: 250
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, into a vein (IV), or inhaled as a mist. The purpose of this study was to see if aztreonam lysinate for inhalation (AI), an investigational formulation of the antibiotic for delivery using the eFlow® Electronic Nebulizer by PARI GmbH, is safe and effective in CF patients with PA.
ELIGIBILITY
Age: >= 6 Years
FEV1: 25 - 75 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

To be included in this study patients must have received three or more courses of TSI (tobramycin solution for inhalation) within the previous 12 months.
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/NCT00104520?term=Air+CF2+and+Cystic+Fibrosis&rank=1
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Following randomization and a 28-day course of tobramycin inhalation solution (TIS), 211 patients who were >6 years old, who had >3 courses of TOBI within the previous year, and who had an FEV1 betwen >25% and <75% of predicted were treated with 75 mg AZLI or placebo, twice or three times daily for 28 days, then monitored for 56 days. The primary efficacy endpoint was time to need for additional inhaled or IV antipseudomonal antibiotics. AZLI treatment increased median time to need for additional antipseudomonal antibiotics for symptoms of pulmonary exacerbation by 21 days, compared with placebo (AZLI, 92 days; placebo, 71 days; P=0.007).

Secondary Efficacy:

AZLI also improved mean CFQ-R Respiratory scores (5.01 points, P=0.02), improved FEV1 (6.3%, P=0.001), and decreased sputum PA density (-0.66 log10 CFU/gram, P=0.006) compared with placebo.

Safety:

Adverse events reported for AZLI and placebo were comparable and consistent with CF lung disease.

Citation:

Am J Respir Crit Care Med 2008;178(9):921-8

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