Observational study on the long-term effects of CFTR modulators in cystic fibrosis patients
Canadian Observational Study Evaluating the Long-term IMPACT of CFTR (Can-IMPACT CF)
This study looks at how well CFTR modulator treatments, like Trikafta, work for people with cystic fibrosis over time by gathering health information and feedback from patients across Canada.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 2 sites (Vancouver, British Columbia and 1 other locations) |
| Trial ID | NCT05200429 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate health trends in cystic fibrosis patients across Canada who are receiving CFTR modulator treatments, specifically focusing on Trikafta. Researchers will collect clinical data from routine care, patient-reported outcomes through surveys, and biological samples for a biobank. The goal is to determine the long-term effectiveness of these treatments and identify which therapies work best for individual patients. By analyzing this data, the study seeks to provide insights into the impact of CFTR modulators on the health of cystic fibrosis patients over time.
Who should consider this trial
Good fit: Ideal candidates for this study are cystic fibrosis patients who are either starting or switching CFTR modulator therapy within the next 30 days.
Not a fit: Patients with known contraindications to CFTR modulator therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for cystic fibrosis patients, enhancing their quality of life and health outcomes.
How similar studies have performed: Other studies have shown promising results with CFTR modulator therapies, indicating potential for significant advancements in cystic fibrosis treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vancouver, British Columbia and 1 other locations
- British Columbia Children's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- St Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Jonathan Rayment, MDCM — University of British Columbia
- Study coordinator: Alam Lakhani
- Email: alam.lakhani@cw.bc.ca
- Phone: 604-875-2345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.