AIR-CF1: Study Design

THE EFFICACY AND SAFETY OF CAYSTON HAS BEEN ESTABLISHED THROUGH MULTIPLE TRIALS 1-3

AIR-CF1 1

AIR-CF1 (pivotal study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of CAYSTON.

  • n=80 TID
  • One 28-day course of CAYSTON therapy
  • Study length: 1.5 months

AIR-CF2 2

AIR-CF2 was a randomized, double-blind, placebo-controlled trial that contributed to the safety and microbiology profile of CAYSTON.

  • n=135 (69 BID, 66 TID)
  • One 28-day course of CAYSTON therapy, after 1 course of tobramycin nebulizer solution (TNS)
  • Study length: 4 months

AIR-CF3 3

AIR-CF3 was an open-label follow-on trial that assessed the safety and microbiology profile of CAYSTON.

  • n=274 (85 BID, 189 TID)
  • Up to nine 28-day courses of CAYSTON
  • Study length: 18 months

The AIR-CF1 Study Was the Pivotal Trial That Evaluated the Efficacy and Safety Profile of CAYSTON

AIR-CF1: Study Design

Study Description

  • AIR-CF1 was a Phase 3, double-blind, multicenter, international, randomized, placebo-controlled trial of 164 patients (≥7 years old with FEV1 of 25%-75% predicted) with CF and Pa to evaluate CAYSTON over a period of 28 days of treatment

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 relative change in FEV1 (L)1

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

*1 course = 28 days of treatment.

AIR-CF1: baseline characteristics1

CAYSTON AIR-CF1: Baseline patient CAYSTON AIR-CF1: Baseline patient
Learn About AIR-CF1 Study Efficacy Results
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