NCT05279040Recruiting
Trikafta Exercise Study in Cystic Fibrosis
Long-term Effects of Elexacaftor/Tezacaftor/Ivacaftor (Trikafta) on Exertional Symptoms, Exercise Performance, Ventilatory Responses, and Body Composition in Adults With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 8 Nov 2021
- Start date
- 10 Nov 2021
- Primary completion date
- Jan 2027
- Lead sponsor
- University of British Columbia
- Diseases
- Cystic fibrosis
- NCT number
- NCT05279040
What you commit to
- Study type: Observational
- Planned participants: 20
- From 10 Nov 2021 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- History of organ transplantation
Other
- Contraindications to clinical exercise testing
- Use of supplemental oxygen or desaturation less than 85% with exercise
- Diagnosis of pneumothorax in the past 4 weeks
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UBC Centre for Heart Lung Innovation, St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.