Prednisone in Cystic Fibrosis Pulmonary Exacerbations

  • STATUS
    Recruiting
  • End date
    May 19, 2023
  • participants needed
    84
  • sponsor
    The Hospital for Sick Children
Updated on 19 June 2021

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.

Details
Condition Cystic Fibrosis Pulmonary Exacerbation
Treatment prednisone, placebos
Clinical Study IdentifierNCT03070522
SponsorThe Hospital for Sick Children
Last Modified on19 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of CF by newborn screening or at least one clinical feature of CF, AND either (a) or (b) as follows
A documented sweat chloride 60 mEq/L by quantitative pilocarpine iontophoresis
A genotype with two identifiable CF-causing mutations
Age > 6 years old
Acute pulmonary exacerbation treated with IV antibiotics as previously defined 10% relative drop in FEV1 from baseline at the time of exacerbation
Informed consent by patient or parent/legal guardian
Ability to reproducibly perform pulmonary function testing
Ability to comply with medication use including the ability to take capsules, study visits and study procedures as judged by the site investigator

Exclusion Criteria

A respiratory tract culture positive for Burkholderia cenocepacia in the 12 months prior to enrollment
A respiratory tract culture positive for Mycobacterium abscessus in the 12 months prior to enrollment
Treatment with IV or oral corticosteroids within 2 weeks of enrollment or from Day 0-Day 7 of the pulmonary exacerbation
Active allergic bronchopulmonary aspergillosis (ABPA) at the time of enrollment as determined by treating physician
Asthma related exacerbation at enrollment as defined by the treating physician based on clinically compatible symptoms (eg. wheeze)
History of avascular necrosis or pathologic bone fracture
Uncontrolled hypertension with end organ damage
Active gastrointestinal bleeding
Status post lung or other organ transplantation
Pregnancy
Lactose intolerance (contained in placebo)
On Lumacaftor-Ivacaftor (Orkambi) at the time of exacerbation
Investigational drug use within 30 days prior to enrollment visit
Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator
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