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Prednisone in Cystic Fibrosis Pulmonary Exacerbations

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03070522
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Hospital for Sick Children
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cystic Fibrosis Pulmonary Exacerbation

Arms & Interventions

Arms

Active Comparator: Placebo

Placebo

Active Comparator: Treatment

Prednisone

Interventions

Drug: - Prednisone

oral prednisone for 7 days during pulmonary exacerbation

Drug: - Placebos

Placebo

Contact a Trial Team

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