Status:
COMPLETED
Orkambi Exercise Study
Lead Sponsor:
University of British Columbia
Conditions:
Lung; Disease
Cystic Fibrosis
Eligibility:
All Genders
19+ years
Brief Summary
Shortness of breath (dyspnea) during exercise is a major source of distress and is a commonly reported symptom in patients with cystic fibrosis (CF). A recent treatment option known as Orkambi, which ...
Detailed Description
Advances in therapies and patient care have led to dramatic improvements in cystic fibrosis (CF) survival. Consequently, CF patients are living longer with varying degrees of lung function impairment....
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CF and homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- Plan to initiate Orkambi™ by the treating physician within 30 days of the enrolment visit
- Aged 19 years or older
- Stable clinical status based on clinical judgment of the treating physicians (Drs Wilcox, Quon or Goodwin)
- Forced Expiratory Volume in 1 second (FEV1.0) \< 90% predicted
- Body mass index greater than 16 or less than 30 kg/m2
- Currently non-smoking or a past smoking history of less than 20 pack-years
- Able to read and understand English
Exclusion
- A disease other than CF that could importantly contribute to dyspnea or exercise limitation
- Chronic airway infection with Mycobacterium abscessus, Burkholderia cepacia complex, or other organisms with infection control implications based on the treating physicians
- Contraindications to clinical exercise testing
- Use of supplemental oxygen or desaturation less than 85% with exercise
- Diagnosis of pneumothorax in the past 4 weeks
- History of organ transplantation
Key Trial Info
Start Date :
July 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02821130
Start Date
July 1 2016
End Date
June 1 2020
Last Update
November 17 2020
Active Locations (1)
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1
UBC James Hogg Research Centre, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6