NCT06147778Completed
Performances and Safety of MuCopilot, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 31 Oct 2023
- Start date
- 18 Sept 2024
- Primary completion date
- 24 Sept 2025
- Lead sponsor
- Ad scientiam
- Diseases
- Cystic fibrosis
- NCT number
- NCT06147778
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 18 Sept 2024 to the primary completion date, 24 Sept 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of lung transplantation
- Any medical condition that could interfere with the proper conduct and results of the study (investigator's judgement)
Other
- Pregnant women and women who are breastfeeding
- Illiteracy in French
- Inability to use a smartphone or MuCopilot application
- Persons under legal protection (i.e guardianship or curatorship)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Lyon Sud (Adultes) Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| APHM - Hôpital Nord de Marseille Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Centre de compétence Maladies pulmonaires rares Hôpital Pasteur CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| American Memorial Hospital Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Centre de Perharidy, Fondation Idlys Coordinator of this site? Confirm its status | Roscoff | France | Unknown status |
| CRCM Mixte - Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Hopital Larrey Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.