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.
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.
