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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-Therapy Participants

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.

Trikafta

Intervention Type DRUG

Highly Effective CFTR Modulator Therapy

Interventions

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Trikafta

Highly Effective CFTR Modulator Therapy

Intervention Type DRUG

Other Intervention Names

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Elexacaftor/Tezacaftor/Ivacaftor

Eligibility Criteria

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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