Status:
TERMINATED
MUCOviscidose EXacerbation Outils Connectés Education Thérapeutique
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
Fondation pour la Recherche Médicale
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
Early detection of pulmonary exacerbations (PEx) in Cystic Fibrosis (CF) patients is important to quickly trigger treatment and reduce respiratory damage. The investigators hypothesize that using home...
Detailed Description
BACKGROUND Pulmonary exacerbations (PEx) are the major cause of lung function decline in Cystic Fibrosis (CF) patients leading to respiratory failure. Identifying warning signs of PEx is a priority t...
Eligibility Criteria
Inclusion
- 12 years and over
- Cystic fibrosis confirmed by sweat test or genetic
- Able to understand and respect the protocol and its requirements
- Who signed the consent prior to any other procedure protocolFollowed in the same CF center during the study
- In clinically stable condition - no pulmonary exacerbation requiring intravenous antibiotics - in the previous 4 weeks)
- Prescribed at least one pulmonary medication (eg, inhaled mucolytic, inhaled or oral antibiotic therapy, hypertonic saline)
- Not undergone solid organ transplants
- With smartphone, computer or tablet connected to wifi access
Exclusion
- Patient undergoing solid organ transplant
- Pregnancy or planned pregnancy during the period of the study
- Patient on exclusion period because of other clinical research esearch
- Patients who don't use connected devices during the 3 first months will be excluded from the study.
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03304028
Start Date
October 20 2017
End Date
June 18 2020
Last Update
June 13 2022
Active Locations (7)
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1
CF adults center - Hopital Albert Calmette
Lille, France, 59037
2
CF adults center - Institut du Thorax
Nantes, France, 44093
3
CF pediatrics center - Hopital Mère-Enfant
Nantes, France, 44093
4
CF pediatrics center - Hopital Robert Debré
Paris, France, 75019