NCT07885410

Brief Summary

PERCE-MUCO is a prospective, multicentre, mixed-methods observational study investigating the perceptions, expectations and treatment-change intentions of adults with cystic fibrosis who are currently treated with elexacaftor/tezacaftor/ivacaftor (ETI) or whose treatment has been medically discontinued. The study focuses on patients' stated willingness to switch from ETI to vanzacaftor/tezacaftor/deutivacaftor (VTD), and on the factors associated with this intention, including treatment satisfaction, knowledge and expectations regarding VTD, quality of life, treatment adherence, reported adverse effects, access-related concerns and desired support from an advanced practice nurse. The quantitative component uses a study-specific questionnaire and routine-care CFQ-R 14+ and Morisky-8 data. A qualitative component consists of semi-structured interviews at the Roscoff cystic fibrosis centre.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 9, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

5 months

First QC Date

October 13, 2026

Last Update Submit

October 13, 2026

Conditions

Cystic Fibrosis (CF)

Keywords

CFTR modulator; treatment preference; treatment switching; quality of life; adherence; patient experience; advanced practice nursing

Outcome Measures

Primary Outcomes (1)

  • Intention to switch from ETI to VTD

    Percentage of participants selecting each of three responses to the question: 'If your physician offered VTD tomorrow, what would your position be?' Response options: immediate acceptance; need time to think; refusal. Report proportions and 95% confidence intervals

    At completion of the PERCE-MUCO questionnaire at inclusion (single assessment).

Secondary Outcomes (6)

  • Factors influencing willingness to switch

    At completion of the PERCE-MUCO questionnaire at inclusion.

  • Association between quality of life and intention to switch

    CFQ-R 14+ measurement closest to inclusion, collected from routine care

  • Association between treatment adherence and intention to switch

    Morisky-8 measurement closest to inclusion, collected from routine care

  • Association between reported ETI tolerability and intention to switch

    Adverse effects documented in the medical record and available at inclusion

  • Need for support during a potential treatment transition

    At completion of the PERCE-MUCO questionnaire at inclusion

  • +1 more secondary outcomes

Study Arms (1)

Adults with cystic fibrosis treated with ETI or with medically discontinued ETI

Adults with cystic fibrosis who have received ETI for at least 3 months or whose ETI treatment was discontinued for medical reasons. The study observes treatment preferences and associated characteristics; it does not assign or require a change in treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with cystic fibrosis followed at participating French cystic fibrosis resource and competence centres (CRCMs), who currently receive ETI or whose treatment was medically discontinued. The qualitative interview component is limited to eligible patients followed at the Roscoff CRCM.

You may qualify if:

  • Diagnosis of cystic fibrosis
  • Currently treated with ETI for at least 3 months, OR previously treated with ETI but treatment discontinued for medical reasons

You may not qualify if:

  • Patient objects to the use of their data for this project\\n•
  • Currently receiving the new CFTR modulator VTD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CRCM Caen

Caen, France

NOT YET RECRUITING

CRCM Giens

Giens, France

RECRUITING

CRCM Lille

Lille, France

NOT YET RECRUITING

CRCM Lyon

Lyon, France

NOT YET RECRUITING

CRCM Montpellier

Montpellier, France

RECRUITING

CRCM Paris

Paris, France

NOT YET RECRUITING

CRCM Reims

Reims, France

RECRUITING

CRCM Rennes adultes

Rennes, France

NOT YET RECRUITING

Fondation ILDYS

Roscoff, 29680, France

RECRUITING

CRCM Rouen

Rouen, France

RECRUITING

CRCM Vannes

Vannes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Central Study Contacts

Morgane Auffret, ResearchNurse

CONTACT

0298292523morgane.auffret@ildys.org

Matthieu Pichelin

CONTACT

matthieu.pichelin@ildys.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2026

First Posted

October 21, 2026

Study Start

July 9, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 21, 2026

Record last verified: 2026-10

Locations

FR(11)