Conditions: Cystic Fibrosis
Keywords: Lung disease CF Pulmozyme
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 27
Healthy volunteers: no

Brief summary:
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Dornase alfa intervention 2: placebo
Intervention descriptions: intervention 1: 2.5 mg inhalation dose twice daily for 14±2 days intervention 2: 2.5 mg inhalation dose twice daily for 14±2 days

Protocol document: