AIR-CF1: Study Design

The AIR-CF1 study was the pivotal trial that evaluated the efficacy and safety profile of CAYSTON

CAYSTON AIR-CF1 Study Design chart

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.

*One course = 28 days on treatment, following 28 days off

TREATMENT

  • 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

ENDPOINTS

  • 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)

TREATMENT EXPERIENCE

  • 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

AIR-CF1: baseline characteristics4

CAYSTON AIR-CF1: Baseline patient
Learn About Respiratory Symptoms
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