Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis

NCT06147778 | Completed

• 1 other identifier: ADS-MuControl-2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief Summary

The study aims to evaluate MuCopilot, a smartphone application to measure objective data on lung function (cough and dyspnea tests), global exercise capacity (walking test) and patient-reported outcomes (PROs) of patients with Cystic Fibrosis (CF). These data are collected during unsupervised digital tests performed in the patient's home environment between consultations. The primary objective is to demonstrate the correlation of the MuCopilot digital tests at home (D1) with the results of their standard counterparts (D0) carried out in-clinic. A secondary objective is to determine the accuracy, reliability and reproducibility of tests results, as well as to study the test-retest of the PRO. The study also aims to assess the safety, usability, and satisfaction of the solution. Exploratory objectives include evaluating the relationship between MuCopilot's scores and other standards such as FVC, FEV1/FVC ratio as well as to explore the correlation with the cough monitoring with patient's perception. Patients will be able to download MuCopilot app. They will participate in 1 inclusion visit and 7 follow-up visits, scheduled at Day 1, Day 3, Day 5, Day 7, 1 month, 2 months, 3 months - 1 day. The study will include 70 CF patients and will be conducted in France.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• To demonstrate that the results of the MuCopilot digital tests at home (D1) are associated with the results of their standard counterparts (D0) carried out in-clinic.

  A correlation coefficient will be used to assess the relationship between MuCopilot tests (MSPT) on Day 1 (at home) and the corresponding standard test on Day 0 (in the clinic). The objective will be achieved if the correlation coefficient reaches a minimum of 0.70. A head-to-head comparison will be performed on the following tests: MuCopilot "Mobile Sustained Phonation Test" (MSPT) scores (e.g. maximum phonation time calculated during a sustained phonation assessment) and the FEV1 (air volume exhaled during one second) measured by spirometry at the CF centres

  During the first in-clinic visit : Day 0 and the first at-home assessment : Day 1

• To demonstrate that the results of the MuCopilot digital tests at home (D1) are associated with the results of their standard counterparts (D0) carried out in-clinic.

  A correlation coefficient will be used to assess the relationship between MuCopilot tests (MEWT) on Day 1 (at home) and the corresponding standard test on Day 0 (in the clinic). The objective will be achieved if the correlation coefficient reaches a minimum of 0.70. A head-to-head comparison will be performed on the following tests: MuCopilot "Mobile Endurance Walking Test" (MEWT), i.e. the walking distance (in metres) walked over six minutes on a hard, flat surface at home and the walking distance (in metres) measured during the 6 minute walk test (6MWT) in-clinic

  During the first in-clinic visit : Day 0 and the first at-home assessment : Day 1

Secondary Outcomes (11)

• To confirm that the results of the MuCopilot digital test at-home (M3-1) are correlated with their standard clinical counterparts performed in-clinic (M3).

  During the last in-clinic visit : at Month 3 and the last at-home assessment Month 3 - 1 day

• To evaluate the correlation between MuCopilot the digital tests performed in-clinic, and the results of their standard counterparts performed in-clinic

  During the first in-clinic visit : Day 0 and the last in-clinic visit : Month 3

• To assess intra-patient test-retest reliability of the MuCopilot CF-Scan questionnaire

  During at-home visits at Day 1 and Day 3

• To assess the safety of the mobile application use.

  Throughout the study for all visits in-clinic and at-home Day 0, Day 1, Day 3, Day 5, Day 7, Month 1, Month 2, Month 3-1 day, Month 3

• To assess the satisfaction and user experience with MuCopilot.

  Throughout the study, at-home at Day 7, Month 1, Month 3 - 1 day

Study Arms (1)

MuCopilot comparison to clinical standards

EXPERIMENTAL

Performance of digital tests and questionnaire at Day 0, D1, D3, D5, D7, M1, M2, M3-1 and M3, against clinical standards performed at Day 0 and 3 months.

Device: MuCopilot mobile application

Interventions

MuCopilot mobile application DEVICE

MuCopilot is a software as medical device with three digital tests, to measure patient's with CF, lung function, global exercise capacity and a questionnaire to address CF symptoms and impacts on some aspects of patient's life

MuCopilot comparison to clinical standards

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥ 18 years old) patients living with Cystic Fibrosis (CF)
• Enrolled in or benefiting of a Social Security program
• Having read the information sheet and signed the informed consent form
• Owning a personal smartphone which Operating System (OS) is equal or above 14 for iOS (iPhone) and 8 for Android, and have access to a good internet connexion
• Able to read language in which the mobile application is available and able to understand pictograms on the application

You may not qualify if:

• History of lung transplantation
• Pregnant women and women who are breastfeeding
• Any medical condition that could interfere with the proper conduct and results of the study (investigator's judgement)
• Illiteracy in French
• Inability to use a smartphone or MuCopilot application
• Persons under legal protection (i.e guardianship or curatorship)
• Participation in another clinical interventional study within 30 days prior to selection or current participation in another study that, in the opinion of the investigator, could interfere with the proper conduct and results of the study

Sponsors & Collaborators

• Ad scientiam: lead
• Vertex Pharmaceuticals Incorporated: collaborator

Study Sites (7)

Centre Hospitalier Lyon Sud (Adultes)

Lyon, 69495, France

Location

APHM - Hôpital Nord de Marseille

Marseille, 13015, France

Location

Centre de compétence Maladies pulmonaires rares Hôpital Pasteur CHU de Nice

Nice, 06002, France

Location

American Memorial Hospital

Reims, 51100, France

Location

Centre de Perharidy, Fondation Idlys

Roscoff, 29682, France

Location

CRCM Mixte - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Hôpital Larrey

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Christophe Marguet, MD

  CHU Rouen Charles Nicolle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 28, 2023
• Study Start: September 18, 2024
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

FR (7)