Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Study Overview
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Brief Summary
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Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being sought to achieve the best effect of airway clearance. The primary aim of this study is to assess the efficacy of a new ACT (Simeox) on pulmonary function in children with CF. 40 CF patients with stable respiratory function will be randomized 1:1 to Simeox or conventional chest physiotherapy (CCPT) therapy (control group) and treated at home during 1 month. After a short washout period, patients will be treated at home onto the alternative treatment for 1 month (crossover design). Lung function, quality of life, pulmonary exacerbation and safety will be evaluated at 1 month for each therapy period.

Official Title
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Efficacy of the Simeox Airway Clearance Technology in the Treatment of Children With Clinically Stable Cystic Fibrosis- Cross-over Study With Randomization

Conditions
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Cystic Fibrosis in Children, Airway Clearance Impairment

Intervention / Treatment
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* Device: Simeox
* Other: CCPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject and his or her legally appointed and authorized representative will agree for treatment with Simeox technology willing and able to cooperate and learn new technic of drainage. age 8-18 years, on the date of admission to hospital. confirmed diagnosis of CF as determined by the investigator. able to perform pulmonary tests Exclusion Criteria: History of any illness or any clinical condition that, in the opinion of the investigator, might confound the cooperation or the results of the study or pose an additional risk to the subject in using study technology. This includes, but is not limited to, the following: contraindications to bronchial chest physiotherapy hemoptysis pneumothorax heart disease recent chest surgery recent chest injury history of lung transplantation

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Device group | Device: Simeox<br>* Airway clearance device<br>Other: CCPT<br>* Conventional chest physiotherapy<br>|
| Active Comparator: Conventional chest physiotherapy<br>Control group | Device: Simeox<br>* Airway clearance device<br>Other: CCPT<br>* Conventional chest physiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total lung resistance | Evolution of R5hz - Impulse Oscillometry (IOS) from baseline | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central lung resistance | Evolution of R20hz - Impulse Oscillometry (IOS) from baseline | 1 month | 
| Change in peripheral lung resistance | Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline | 1 month | 
| Change in total lung reactance | Evolution of X5hz -Impulse Oscillometry (IOS) from baseline | 1 month | 
| Change in area of reactance (AX) | Evolution of AX -Impulse Oscillometry (IOS) from baseline | 1 month | 
| Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R) | Evolution of CFQ-R total score (0-100) from baseline | 1 month | 
| Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire | Evolution of respiratory score (0-100) of CFQ-R from baseline | 1 month | 
| Change in Forced Expiratory Volume in 1 second (FEV1) | Evolution of FEV1 (spirometry) from baseline | 1 month | 
| Change in Forced Vital Capacity (FVC) | Evolution of FVC (spirometry) from baseline | 1 month | 
| Change in Residual Volume (RV) | Evolution of RV (body plethysmography) from baseline | 1 month | 
| Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume | Evolution of MEF 25, 50 and 75 (spirometry) from baseline | 1 month | 
| Change in Mean Mid Expiratory Flow (MMEF) | Evolution of MMEF (spirometry) from baseline | 1 month | 
| Change in lung clearance index (LCI) | Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline | 1 month | 
| Pulmonary exacerbation | Rate of pulmonary exacerbation | 1 month | 
| Adverse events | Rate of adverse events related or not related to intervention | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway clearance technique