Clinical trial NCT04096664: Home Airway Clearance in CF Patients
Official title: Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Cystic Fibrosis
Keywords: bronchial clearance
cystic fibrosis
Lead sponsor: Physio-Assist
Sponsor class: INDUSTRY
Collaborators: name: Icadom
First posted: 2019-09-20
Enrollment: 143
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adaptive prospective, randomized, controlled, multicenter trial, with hierarchical sequential analysis.
Primary purpose: TREATMENT

Brief summary: Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree.

By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, post-care, and rehabilitation units, etc...). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves.

The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with Cystic fibrosis
* Stabilization of the disease, defined by an at least 4 weeks period since the end of an exacerbation, stabilization will be let to investigator's judgment.
* Age \>12
* Requiring at least 1 bronchial clearing session each week (regardless of the technique)
* Patient (or patient's legal representative if applicable), capable to read and understand the procedure, and capable to express consent for the study protocol.

Exclusion Criteria:

* Severe pneumothorax or hemoptysis (more than 30ml per 24 hours) within 6 weeks before the inclusion day.
* Patient placed on a transplant waiting list
* Any contraindication to an instrumental bronchial clearance technique
* Patients already own and use SIMEOX at home
* Unavailable patient or patient wishing to move to a different region within three months after inclusion.
* Patient currently participating or having participated to another interventional clinical research within a month prior inclusion date, that may impact the study, this impact is left to the investigator's judgment.
* Persons referred by the French Public Health Code to Articles L1121-5 to L1121-8 (includes all protected persons: pregnant women (confirmed by measurement of the serum human chorionic gonadotropin level for any woman wishing to enter the protocol and under childbearing age \< 60), parturient woman, breastfeeding mother, everyone deprived of his liberty by judicial or administrative decision, everyone subject to a legal protection measure.
* Initiation of treatment with a CFTR modulator within the last 3 months

Primary outcomes:
measure: Respiratory score of CFQ-R questionnaire
timeFrame: Change from baseline at 3 months
measure: Variation of forced expiratory volume in 1 second (FEV1)
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Total score of CFQ-R questionnaire
timeFrame: Change from baseline at 3 months
measure: Safety of use assessed by incidence of Treatment-Emergent Adverse Events
timeFrame: During 3 months of use
measure: Satisfaction assessed by "Treatment Satisfaction Questionnaire for Medication"(TSQM) questionnaire
timeFrame: After 3 months of use
measure: Acceptability assessed by the number of uses of SIMEOX® device
timeFrame: During 3 months of use
measure: Pulmonary forced vital capacity (FVC)
timeFrame: Change from baseline at 3 months
measure: FEV1/ FVC ratio
timeFrame: Change from baseline at 3 months
measure: Forced expiratory flow
timeFrame: Change from baseline at 3 months
measure: Static lung compliance in Liter
timeFrame: Change from baseline at 3 months
measure: Static lung compliance in % of predicted value
timeFrame: Change from baseline at 3 months
measure: Airway resistance
timeFrame: Change from baseline at 3 months
measure: Diffusion capacity for carbon monoxide
timeFrame: Change from baseline at 3 months
measure: Quality of life assessed by EQ-5D 5L questionnaire : a standardized instrument for measuring generic health status
timeFrame: Change from baseline at 3 months
measure: Physical activity assessed by step counts and moderate-to-vigorous physical activity
timeFrame: Change from baseline at 3 months
measure: Sleep quality assessed by sleep efficiency and fragmentation
timeFrame: Change from baseline at 3 months
measure: Fatigue assessed by VAS (visual analogue scale)
timeFrame: During 3 months of use
measure: Dyspnea assessed by mMRC (Modified Medical Research Council) score
timeFrame: Change from baseline at 3 months
measure: Exacerbation rate
timeFrame: After 3 months of use
measure: First exacerbation
timeFrame: During 3 months of use
measure: Hospitalization rate
timeFrame: After 3 months of use
measure: Hospitalization duration
timeFrame: After 3 months of use
measure: Antibiotic therapy
timeFrame: After 3 months of use
measure: Adherence telemonitoring feasibility
timeFrame: After 3 months of use
measure: Acceptability of SIMEOX-ANDROID application assessed by self-questionnaire AES (acceptability E-SCALE)
timeFrame: After 3 months of use
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Angers
country: France
facility: CHU Angers
city: Créteil
country: France
facility: CHI Créteil
city: Grenoble
country: France
facility: Grenoble University Hospital : pneumo-pediatric department
city: Grenoble
country: France
facility: Grenoble University-Affiliated Hospital : Pneumology department
city: Lyon
country: France
facility: CHU Lyon HCL
city: Marseille
country: France
facility: Marseille University Hospital - Pneumology department
city: Montpellier
country: France
facility: Montpellier Hospital Center
city: Nice
country: France
facility: Nice University-Affiliated Hospital : Pneumology department
city: Nice
country: France
facility: Nice University-Affiliated Hospital : Pneumo-pediatric department
city: Paris
country: France
facility: Hôpital Armand-Trousseau
city: Paris
country: France
facility: Hôpital Robert Debré
city: Reims
country: France
facility: CHU Reims
city: Roscoff
country: France
facility: Fondation Ildys
city: Saint-Denis
country: France
facility: CHU Felix Guyon
city: Saint-Pierre
country: France
facility: CHU De la Réunion Site SUD - Pôle Femme-Mère-Enfant
city: Saint-Pierre
country: France
facility: CHU De la Réunion Site SUD
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Larrey
city: Toulouse
country: France
facility: CHU Toulouse pediatric
city: Vannes
country: France
facility: Groupement Hospitalier Brocéliande Atlantique
Study officials:
affiliation: CHUGA
name: Rebecca Hamidfar, MD
role: PRINCIPAL_INVESTIGATOR
References: