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The AIR-CF1 study was the pivotal trial for CAYSTON and assessed respiratory symptoms and lung function
- AIR-CF11 (pivotal study) was a placebo-controlled trial that evaluated the efficacy and safety of CAYSTON.
- AIR-CF22 was a placebo-controlled trial that contributed to the safety and microbiology profile for CAYSTON.
- AIR-CF33 was an open-label follow-on trial that assessed the safety and microbiology profile for CAYSTON.
AIR-CF1: Study Design
AIR-CF1 was a Phase 3, double-blind, multicenter, international, randomized, placebo-controlled clinical trial of 164 patients >7 years old to evaluate CAYSTON in patients with CF and pulmonary Pseudomonas aeruginosa.
*1 course = 28 days on treatment, following 28 days off
- Patients were randomized to receive 28 days of treatment with CAYSTON 75 mg or placebo 3 times a day.
- All patients were required to take a dose of an inhaled bronchodilator (beta-agonist) prior to taking a dose of CAYSTON or placebo.
- Patients received CAYSTON or placebo administered with the Altera® Nebulizer System.
- Primary endpoint was improvement in respiratory symptoms on the last day of treatment as measured by the Respiratory Symptoms Scale of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).1 Respiratory symptoms were also assessed 2 weeks after completion of treatment.
- Secondary endpoint was the mean percent change in FEV1 (L).
- Patients were required to have been off antibiotics for at least 28 days before treatment with study drug.
- Patients were receiving standard care for CF, including drugs for obstructive airway diseases.