Canadian Observational Study Evaluating the Long-term IMPACT of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators on People With CF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trikafta.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Canadian Observational Study Evaluating the Long-term IMPACT of CFTR (Can-IMPACT CF)
Overview
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.
Interventions
- Drug Trikafta
Highly Effective CFTR Modulator Therapy
Primary outcome measures
- To examine the long-term pulmonary and nutritional effects of CFTR modulators. [Time frame: 5 years]
- To assess the long-term impact of CFTR modulators on patient-reported outcome measures including quality of life, disease burden, and physical activity. [Time frame: 5 years]
- To establish a bio-repository to enable further investigations of the effectiveness of CFTR modulator therapies on biological markers and predictors of response. [Time frame: 5 years]
- To establish the benefits of CFTR modulators compared to propensity-score matched historic CF populations followed in the Canadian CF registry. [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 2 centers
- British Columbia Children's Hospital — Vancouver
- St Paul's Hospital — Vancouver
Identifiers
NCT: NCT05200429 · H21-01707