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

University of British Columbia

Status: Enrolling

Conditions: Cystic Fibrosis

Treatments: Drug: Trikafta

Study type: Observational

Funder types: Other

Identifiers

NCT05200429

H21-01707

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prescribed a CFTR modulator therapy and planning to commence modulator therapy within 30 days OR planning to switch modulator therapies within 30 days
• Participates in the Canadian Cystic Fibrosis Registry (CCFR)
• Informed consent by participant, or parent/legal guardian or assent

Exclusion criteria

• Known contraindications to CFTR modulator therapy

Trial design

500 participants in 1 patient group

Pre-Therapy Participants

Description:

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.

Treatment:

Drug: Trikafta