Effects of Trikafta on exercise and breathing in cystic fibrosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates how the drug Trikafta affects shortness of breath and exercise performance in patients with cystic fibrosis (CF). It aims to evaluate the impact of this combination therapy on exercise capacity, which is a critical predictor of survival in CF. Participants will undergo standardized exercise tests to assess dyspnea and performance while on Trikafta. The study seeks to provide insights into the potential health improvements associated with this treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• UBC Centre for Heart Lung Innovation, St. Paul's Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Jordan A Guenette, PhD — University of British Columbia
• Study coordinator: Satvir S Dhillon, MSc
• Email: satvir.dhillon@hli.ubc.ca
• Phone: 6048068835

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.