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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
oral prednisone for 7 days during pulmonary exacerbation
Placebo
The Governers of The University of Calgary - Alberta Health Services
Calgary, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
London Health Sciences Centre - Lawson Health Research Institute
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Unity Health Toronto - St. Michael's Hospital
Toronto, Ontario, Canada
SickKids
Toronto, Ontario, Canada
The Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec, Canada
CHU de Quebec-Universite Laval
Québec, Quebec, Canada
...and 2 more locations
Lung function recovery
The proportion of subjects who achieve \>90% of their baseline FEV1 % predicted at day 14 of IV antibiotic treatment for a PEx in each treatment arm.
Time frame: At 14 days of antibiotic therapy
lung function recovery at follow up visit
The proportion of subjects who achieve \>90% of their baseline FEV1 % predicted
Time frame: 1 month follow up
change in pulmonary function testing
change in pulmonary function testing
Time frame: at day 7, 14 and 1 month follow up
quality of life as measured by CFQ-R questionnaire
quality of life
Time frame: at day 7, 14 and 1 month follow up
quality of life as measured by CF Respiratory Symptom Diary
quality of life
Time frame: at day 7, 14 and 1 month follow up
length of hospitalization
length of hospitalization
Time frame: Through study completion, up to 100 weeks
time to subsequent pulmonary exacerbation
time to subsequent pulmonary exacerbation
Time frame: 1 year follow up time
number of adverse events
number of adverse events
Time frame: At day day 14 of antibiotic therapy and 1 month follow up
change in sputum inflammatory markers
change in sputum inflammatory markers
Time frame: at day 7, 14 and 1 month follow up
change in serum inflammatory markers
change in serum inflammatory markers
Time frame: at day 7, 14 and 1 month follow up
Duration of antibiotic treatment
Duration of antibiotic treatment
Time frame: Through study completion, up to 100 weeks
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