Long-term Effects of Elexacaftor/Tezacaftor/Ivacaftor (Trikafta) on Exertional Symptoms, Exercise Performance, Ventilatory Responses, and Body Composition in Adults With Cystic Fibrosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
UBC Centre for Heart Lung Innovation, St. Paul's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Satvir S Dhillon, MSc
satvir.dhillon@hli.ubc.ca
6048068835
Backup
Jordan Guenette, PhD
jordan.guenette@hli.ubc.ca
16048068835
Time Frame
Start Date: 2021-11-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
Cystic Fibrosis Patients
Participants diagnosed with cystic fibrosis who will be initiating Trikafta treatment
Related Therapeutic Areas
Sponsors
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov