Actively Recruiting

Age: 19Years +
All Genders
NCT05279040

Trikafta Exercise Study in Cystic Fibrosis

Led by University of British Columbia · Updated on 2025-03-26

20

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Trikafta Exercise Study in Cystic Fibrosis

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UBC Centre for Heart Lung Innovation, St. Paul's Hospital

Vancouver, British Columbia, Canada, V6Z 1Y6

Actively Recruiting

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Research Team

S

Satvir S Dhillon, MSc

CONTACT

J

Jordan Guenette, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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