Status:
RECRUITING
Trikafta Exercise Study in Cystic Fibrosis
Lead Sponsor:
University of British Columbia
Conditions:
Cystic Fibrosis
Lung Diseases
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 drug treatment option known as Trikafta, ...
Detailed Description
Justification: Advances in therapies and patient care have led to dramatic improvements in CF survival. Consequently, CF patients are living longer with varying degrees of lung function impairment. Dy...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CF and at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- Plan to initiate Trikafta 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 physician
- Forced Expiratory Volume in 1 second (FEV1.0) \< 90% predicted
- Body mass index greater than 16 or less than 30 kg/m\^2
- Currently non-smoking or a past smoking history of less than 20 pack-years
- Able to read and understand English
- Fully vaccinated (at least 2 doses) for Covid-19
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 :
November 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05279040
Start Date
November 10 2021
End Date
December 1 2025
Last Update
March 26 2025
Active Locations (1)
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1
UBC Centre for Heart Lung Innovation, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6