Status:

COMPLETED

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

Lead Sponsor:

Ad scientiam

Collaborating Sponsors:

Vertex Pharmaceuticals Incorporated

Conditions:

Cystic Fibrosis

Eligibility:

All Genders

18+ years

Phase:

NA

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 outcom...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

September 18 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 24 2025

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT06147778

Start Date

September 18 2024

End Date

September 24 2025

Last Update

November 28 2025

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Centre Hospitalier Lyon Sud (Adultes)

Lyon, France, 69495

2

APHM - Hôpital Nord de Marseille

Marseille, France, 13015

3

Centre de compétence Maladies pulmonaires rares Hôpital Pasteur CHU de Nice

Nice, France, 06002

4

American Memorial Hospital

Reims, France, 51100