Trikafta Exercise Study in Cystic Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorUniversity of British Columbia
About this trial
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, which contains elexacaftor, tezacaftor, and ivacaftor, may be used in patients with CF to help improve lung health. However, the effects of this combination therapy on dyspnea and exercise performance, a known predictor of survival in CF, are not clear. The investigators aim to understand the effects of Trikafta on these symptoms and to gain new insight into the potential health improvements in CF from using this treatment option.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Trikafta
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov