Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

Study Overview
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Brief Summary
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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, postcare, 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.

Official Title
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Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study

Conditions
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Pulmonary Cystic Fibrosis

Intervention / Treatment
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* Device: SIMEOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: one of the 56 first patients of HOME-CARE SIMEOX study same criteria as HOME-CARE SIMEOX study Exclusion Criteria: same criteria as HOME-CARE SIMEOX study

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled, multicenter trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIMEOX<br>Use the device for 3 months in addition to usual care | Device: SIMEOX<br>* Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX<br>|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary static hyperinflation assessed by residual volume | Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group. | Change from baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use assessed by the duration of use of SIMEOX® device | Assess the duration of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the use by patient of the device. | During 3 months of use | 
| Inspiratory capacity | Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group | Change from baseline at 3 months | 
| Residual functional capacity (RFC) | Relative variation of Residual functional capacity (RFC) in liter in the SIMEOX® treated group versus control group | Change from baseline at 3 months | 
| Total lung capacity (TLC) | Relative variation of Total lung capacity (TLC) in liter in the SIMEOX® treated group versus control group | Change from baseline at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchial clearance, cystic fibrosis