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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiration Disorders Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trikafta

Drug

Highly Effective CFTR Modulator Therapy

Other names: Elexacaftor/Tezacaftor/Ivacaftor

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alam Lakhani

CONTACT

[email protected]

604-875-2345 ext. 7606

Britney Ha

CONTACT

[email protected]

604-875-2345 ext. 7606

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: Can-IMPACT CF

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Jan 20, 2022
Registry last updated: Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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