Trikafta Exercise Study in Cystic Fibrosis

Sponsor
University of British Columbia
Study ID
NCT05279040
Status
Recruiting
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Conditions

  • Cystic Fibrosis
  • Lung Diseases

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trikafta — DRUG
    Elexacaftor/Tezacaftor/Ivacaftor combination therapy

Study Details

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.

Key Dates

First listed
Mar 15, 2022
Start date
Nov 10, 2021
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Cystic Fibrosis Patients
    Participants diagnosed with cystic fibrosis who will be initiating Trikafta treatment

Primary Outcome Measure

Change in Iso-time Dyspnea Rating From Baseline (Visit 2) to Visit 3 and 4 During Constant-load Exercise Tests. [ Time Frame: Baseline (i.e., Visit 2), 12 months post Trikafta initiation (i.e., Visit 3), and 24 months post Trikafta initiation (i.e., Visit 4) ]

Central Contacts

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