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

Cystic Fibrosis Clinical Trial

— Can-IMPACT CF  

Official title:

Canadian Observational Study Evaluating the Long-term IMPACT of CFTR (Can-IMPACT CF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200429
• Other study ID #: H21-01707
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2022
• Source: University of British Columbia
• Contact: Alam Lakhani
• Phone: 604-875-2345
• Email: alam.lakhani[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Trikafta
Highly Effective CFTR Modulator Therapy

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the long-term pulmonary and nutritional effects of CFTR modulators.		5 years
Primary	To assess the long-term impact of CFTR modulators on patient-reported outcome measures including quality of life, disease burden, and physical activity.		5 years
Primary	To establish a bio-repository to enable further investigations of the effectiveness of CFTR modulator therapies on biological markers and predictors of response.		5 years
Primary	To establish the benefits of CFTR modulators compared to propensity-score matched historic CF populations followed in the Canadian CF registry.		5 years