Phase
Condition
Cystic Fibrosis
Scar Tissue
Lung Injury
Treatment
Placebos
Prednisone
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of CF by newborn screening or at least one clinical feature of CF, ANDeither (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, studyvisits and study procedures as judged by the site investigator
Exclusion
Exclusion Criteria:
A respiratory tract culture positive for Burkholderia cenocepacia in the 12 monthsprior to enrollment
A respiratory tract culture positive for Mycobacterium abscessus in the 12 monthsprior 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 asdetermined by treating physician
Asthma related exacerbation at enrollment as defined by the treating physician basedon 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 ofthe study data as determined by site investigator
Study Design
Connect with a study center
The Governers of The University of Calgary - Alberta Health Services
Calgary, Alberta T2N 4N1
CanadaSite Not Available
British Columbia Children's Hospital
Vancouver, British Columbia V6H 3N1
CanadaSite Not Available
St. Paul's Hospital
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
London Health Sciences Centre - Lawson Health Research Institute
London, Ontario N6C 2R5
CanadaSite Not Available
The Ottawa Hospital
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
SickKids
Toronto, Ontario M5G1X8
CanadaSite Not Available
Unity Health Toronto - St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Centre hospitalier universitaire Sainte-Justine
Montréal, Quebec H3T 1C5
CanadaSite Not Available
The Centre hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec H2X A09
CanadaSite Not Available
CHU de Quebec-Universite Laval
Quebec City, Quebec G1R 2J6
CanadaSite Not Available
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Quebec City, Quebec G1V 4G5
CanadaSite Not Available
University of Saskatchewan - Saskatchewan Health Authority
Saskatoon, Saskatchewan S7N 0W8
CanadaSite Not Available
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