Canadian Observational Study Evaluating the Long-term IMPACT of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators on People With CF

Sponsor
University of British Columbia
Study ID
NCT05200429
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

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

Interventions

  • Trikafta — DRUG
    Highly Effective CFTR Modulator Therapy

Study Details

This observational study intends to investigate health trends and data in cystic fibrosis patients all across Canada that are receiving modulator treatment so researchers can determine if CFTR treatments are effective over a long period of time and if so, which treatments work best for each individual. The study will collect clinical data from routine standard of care, patient reported outcomes via survey data and samples for a biobank.

Key Dates

First listed
Jan 20, 2022
Start date
Nov 1, 2021
Status verified
Jan 2022
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Pre-Therapy Participants
    All CF people with CF who do not have any known contraindications to CFTR modulator therapy and will be initiated on CFTR modulator therapy by their treating physician as part of clinical care are eligible and will be asked to participate in this study.

Primary Outcome Measure

To examine the long-term pulmonary and nutritional effects of CFTR modulators. [ Time Frame: 5 years ]

Central Contacts

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