NCT03070522

Prednisone in Cystic Fibrosis Pulmonary Exacerbations

Randomized Controlled Trial of Prednisone in Cystic Fibrosis Pulmonary Exacerbations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This will be a 5 year randomized, double blind, placebo controlled trial of 7 days of oral prednisone in cystic fibrosis (CF) patients receiving intravenous (IV) antibiotic treatment for a pulmonary exacerbation at the Hospital for Sick Children and other study sub-sites across Canada. The intervention will be oral prednisone 2 mg/kg/day (max 60 mg) divided twice daily for 7 days as an adjunctive therapy for pulmonary exacerbations in CF patients who have not recovered their baseline forced expiratory volume in 1 second (FEV1) after 7 days of IV antibiotic treatment. The primary outcome will be the proportion of subjects who achieve \>90% of their baseline FEV1 % predicted at day 14 of IV antibiotic treatment for a pulmonary exacerbation in each treatment arm.

Conditions

• Cystic Fibrosis Pulmonary Exacerbation

Interventions

Type	Name	Description
DRUG	Prednisone	oral prednisone for 7 days during pulmonary exacerbation
DRUG	Placebos	Placebo

Timeline

• Start date: 2017-05-01
• Primary completion: 2023-10-07
• Completion: 2023-10-07
• First posted: 2017-03-03
• Last updated: 2024-07-01

Locations

12 sites across 1 country: Canada