Active Comparator: Study Design
The active comparator trial studied the efficacy and safety of Cayston compared to Tobramycin Nebulizer Solution (TNS)
Active Comparator Trial: Study design8
Study Description
- Open-label, randomized, parallel-group, active comparator study of 268 patients ≥6 years of age with FEV1 ≤75% predicted, with CF and pulmonary Pa infection
- The study was conducted in 91 CF centers in Europe and the US from 2008 to 2010
Treatment
- Patients were randomized (1:1) to three 28-day on/off treatment courses of CAYSTON 75 mg, 3 times daily or tobramycin nebulizer solution (TNS) 300 mg, twice daily
- The 26-week active-comparator period was followed by an optional, 24-week, open-label, single-arm, extension period of 3 CAYSTON treatment cycles for eligible patients at European study sites
- Additional TNS use was prohibited during the Active Comparator period
- Additional antipseudomonal antibiotics could be administered for symptoms consistent with the diagnosis of acute pulmonary exacerbation
- Patients receiving additional antipseudomonal antibiotics at any point after randomization could continue study treatment
Co-primary Endpoints
- Superiority of CAYSTON for actual change in FEV1% predicted across 3 treatment cycles
- Non-inferiority of CAYSTON relative change in FEV1% predicted at Day 28
Treatment Experience
- TNS use ≥84 days in the previous year was reported for 85.1% of patients
- Patients with a history of intolerance of TNS were excluded from study enrollment
Active Comparator Trial: Baseline demographics and clinical characteristics8
*n=131, 131, and 262 for 3 columns.
†Approved indication is for patients with FEV1 ≥25% or ≤75% predicted.
‡Enrollment included ≤40 patients with <84 days inhaled tobramycin use in the previous year. One patient was mistakenly stratified to ≥84 days, and 2 patients were mistakenly stratified to <84 days.
