Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Physio-Assist40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cystic Fibrosis in Children Airway Clearance Impairment

Interventions

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in total lung resistance

Evolution of R5hz - Impulse Oscillometry (IOS) from baseline

Time frame: 1 month

Secondary Outcomes

Change in central lung resistance

Evolution of R20hz - Impulse Oscillometry (IOS) from baseline

Time frame: 1 month

Change in peripheral lung resistance

Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline

Time frame: 1 month

Change in total lung reactance

Evolution of X5hz -Impulse Oscillometry (IOS) from baseline

Time frame: 1 month

Change in area of reactance (AX)

Evolution of AX -Impulse Oscillometry (IOS) from baseline

Time frame: 1 month

Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R)

Evolution of CFQ-R total score (0-100) from baseline

Time frame: 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

Time frame: 1 month

Change in Forced Expiratory Volume in 1 second (FEV1)

Evolution of FEV1 (spirometry) from baseline

Time frame: 1 month

Change in Forced Vital Capacity (FVC)

Evolution of FVC (spirometry) from baseline

Time frame: 1 month

Change in Residual Volume (RV)

Evolution of RV (body plethysmography) from baseline

Time frame: 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

Time frame: 1 month

Change in Mean Mid Expiratory Flow (MMEF)

Evolution of MMEF (spirometry) from baseline

Time frame: 1 month

Change in lung clearance index (LCI)

Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline

Time frame: 1 month

Pulmonary exacerbation

Rate of pulmonary exacerbation

Time frame: 1 month

Adverse events

Rate of adverse events related or not related to intervention

Time frame: 1 month

Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes