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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03070522
Other study ID # REB1000053825
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 1, 2017
Est. completion date October 7, 2023

Study information

Verified date April 2024
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date October 7, 2023
Est. primary completion date October 7, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Diagnosis of CF by newborn screening or at least one clinical feature of CF, AND either (a) or (b) as follows: 2. A documented sweat chloride = 60 mEq/L by quantitative pilocarpine iontophoresis 3. A genotype with two identifiable CF-causing mutations 4. Age > 6 years old. 5. Acute pulmonary exacerbation treated with IV antibiotics as previously defined 10% relative drop in FEV1 from baseline at the time of exacerbation 6. Informed consent by patient or parent/legal guardian 7. Ability to reproducibly perform pulmonary function testing 8. 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: 1. A respiratory tract culture positive for Burkholderia cenocepacia in the 12 months prior to enrollment 2. A respiratory tract culture positive for Mycobacterium abscessus in the 12 months prior to enrollment 3. Treatment with IV or oral corticosteroids within 2 weeks of enrollment or from Day 0-Day 7 of the pulmonary exacerbation 4. Active allergic bronchopulmonary aspergillosis (ABPA) at the time of enrollment as determined by treating physician 5. Asthma related exacerbation at enrollment as defined by the treating physician based on clinically compatible symptoms (eg. wheeze) 6. History of avascular necrosis or pathologic bone fracture 7. Uncontrolled hypertension with end organ damage 8. Active gastrointestinal bleeding 9. Status post lung or other organ transplantation 10. Pregnancy 11. Lactose intolerance (contained in placebo) 12. On Lumacaftor-Ivacaftor (Orkambi) at the time of exacerbation 13. Investigational drug use within 30 days prior to enrollment visit 14. Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Prednisone
oral prednisone for 7 days during pulmonary exacerbation
Placebos
Placebo

Locations

Country Name City State
Canada The Governers of The University of Calgary - Alberta Health Services Calgary Alberta
Canada London Health Sciences Centre - Lawson Health Research Institute London Ontario
Canada Centre hospitalier universitaire Sainte-Justine Montréal Quebec
Canada The Centre hospitalier de l'Université de Montréal (CHUM) Montréal Quebec
Canada The Ottawa Hospital Ottawa Ontario
Canada CHU de Quebec-Universite Laval Quebec City Quebec
Canada Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Quebec City Quebec
Canada University of Saskatchewan - Saskatchewan Health Authority Saskatoon Saskatchewan
Canada SickKids Toronto Ontario
Canada Unity Health Toronto - St. Michael's Hospital Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
The Hospital for Sick Children Canadian Cystic Fibrosis Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At 14 days of antibiotic therapy
Secondary lung function recovery at follow up visit The proportion of subjects who achieve >90% of their baseline FEV1 % predicted 1 month follow up
Secondary change in pulmonary function testing change in pulmonary function testing at day 7, 14 and 1 month follow up
Secondary quality of life as measured by CFQ-R questionnaire quality of life at day 7, 14 and 1 month follow up
Secondary quality of life as measured by CF Respiratory Symptom Diary quality of life at day 7, 14 and 1 month follow up
Secondary length of hospitalization length of hospitalization Through study completion, up to 100 weeks
Secondary time to subsequent pulmonary exacerbation time to subsequent pulmonary exacerbation 1 year follow up time
Secondary number of adverse events number of adverse events At day day 14 of antibiotic therapy and 1 month follow up
Secondary change in sputum inflammatory markers change in sputum inflammatory markers at day 7, 14 and 1 month follow up
Secondary change in serum inflammatory markers change in serum inflammatory markers at day 7, 14 and 1 month follow up
Secondary Duration of antibiotic treatment Duration of antibiotic treatment Through study completion, up to 100 weeks
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