NCT05279040 Trikafta Exercise Study in Cystic Fibrosis
| NCT ID | NCT05279040 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-11-10 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2021-11-10 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Jordan A Guenette, PhD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT05279040 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05279040 currently recruiting?
Yes, NCT05279040 is actively recruiting participants. Contact the research team at satvir.dhillon@hli.ubc.ca for enrollment information.
Where is the NCT05279040 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05279040 clinical trial?
NCT05279040 is sponsored by University of British Columbia. The principal investigator is Jordan A Guenette, PhD at University of British Columbia. The trial plans to enroll 20 participants.