Effectiveness of CFTR Modulators According to Co-therapy

Is Effectiveness of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators Impacted by Co-therapy? A Population-based Comparative Effectiveness Study Using Data From French Cystic Fibrosis Registry Linked to French National Healthcare Insurance Database

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05663255

Acronym

MODUCO

Enrollment

1990

Registered

2022-12-23

Start date

2023-03-01

Completion date

2024-12-31

Last updated

2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis, CFTR modulators, co-therapy, SNDS

Brief summary

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).

Interventions

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

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Lung function	two years	Change in the best forced expiratory volume in 1 second (FEV1) % predicted, measured during the year (A+1) compared to the year of initiation (A0) of CFTR modulator. The best FEV1 of the year is collected annually in the French CF Registry.

Contacts

Primary ContactIsabelle DURIEU, MD

isabelle.durieu@chu-lyon.fr0033 (0)4 78 86 13 52

Backup ContactMarie VIPREY, MD

marie.viprey@chu-lyon.fr0033 (0)4 72 11 51 39

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026