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Prednisone in Cystic Fibrosis Pulmonary Exacerbations — PIPE  

Cystic Fibrosis Pulmonary Exacerbation Clinical Trial

Official title:
Randomized Controlled Trial of Prednisone in Cystic Fibrosis Pulmonary Exacerbations

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03070522
Study type Interventional
Source The Hospital for Sick Children
Contact
Status Completed
Phase Phase 3
Start date May 1, 2017
Completion date October 7, 2023
View Details
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