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Effectiveness of CFTR Modulators According to Co-therapy

NCT ID: NCT05663255

Last Updated: 2022-12-23

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

UNKNOWN

Total Enrollment

1990 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-12-31

Brief Summary

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Unless CFTR modulators are highly effective, the introduction of CFTR (Cystic fibrosis transmembrane conductance regulator) modulators could lead to concomitant reduction or discontinuation of respiratory co-therapies in real-life. Such reduction/discontinuation of respiratory co-therapies could lead to an overall decrease of the effectiveness of CF care.

MODUCO study aims: 1) to compare the clinical effectiveness on lung function and pulmonary exacerbation of CFTR modulator during the year of initiation, according to level of co-therapy among CF patients; 2) to describe the nature and level of respiratory co-therapies (azithromycin, RhDNase, inhaled antibiotics) in the year before the initiation of CFTR modulator; 3) to describe the changes in respiratory co-therapies during the first and the second year following the initiation of CFTR modulator and compare between the two CFTR modulators; 4) to describe adherence to CFTR modulator during the first and the second year following its initiation; 5) to study the association between the nature of respiratory co-therapies and adherence to CFTR modulator during the first and the second year following its initiation.

A national population-based comparative effectiveness study will be conducted, based on retrospective analysis of clinical and prescription data of the French CF registry linked with the French national health data system (SNDS).

Detailed Description

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Conditions

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Cystic Fibrosis

Keywords

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Cystic Fibrosis CFTR modulators co-therapy SNDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Exposed group

Patients treated with CFTR modulator with at least the discontinuation of one respiratory co-therapy (azithromycin, RhDNase, or inhaled antibiotics) during the year of initiation (A0) of CFTR modulator.

Discontinuation of respiratory co-therapy (azithromycin, RhDNase, or inhaled antibiotics)

Intervention Type DRUG

Discontinuation or reduction of at least one respiratory co-therapy (azithromycin, RhDNase, or inhaled antibiotics)

Control group

Patients treated with CFTR modulator without any discontinuation of respiratory co-therapy (azithromycin, RhDNase, inhaled antibiotics) during the year of initiation (A0) of CFTR modulator.

No interventions assigned to this group

Interventions

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Discontinuation of respiratory co-therapy (azithromycin, RhDNase, or inhaled antibiotics)

Discontinuation or reduction of at least one respiratory co-therapy (azithromycin, RhDNase, or inhaled antibiotics)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \- CF patients aged 6 years and more,
* Treated at least 6 months by ivacaftor or lumacaftor/ivacaftor or elexacaftor/tezacaftor/ivacaftor,
* Included in the French CF registry,
* For whom probabilistic matching with the SNDS database has succeeded.

Exclusion Criteria

* none
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Isabelle DURIEU, MD

Role: CONTACT

Phone: 0033 (0)4 78 86 13 52

Email: [email protected]

Marie VIPREY, MD

Role: CONTACT

Phone: 0033 (0)4 72 11 51 39

Email: [email protected]

Other Identifiers

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69HCL20_0066

Identifier Type: -

Identifier Source: org_study_id