Cystic Fibrosis in Children, Airway Clearance Impairment
Conditions
Keywords
Airway clearance technique
Brief summary
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.
Interventions
DEVICESimeox
Airway clearance device
OTHERCCPT
Conventional chest physiotherapy
Sponsors
Physio-Assist
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total lung resistance | 1 month | Evolution of R5hz - Impulse Oscillometry (IOS) from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in peripheral lung resistance | 1 month | Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline |
| Change in total lung reactance | 1 month | Evolution of X5hz -Impulse Oscillometry (IOS) from baseline |
| Change in area of reactance (AX) | 1 month | Evolution of AX -Impulse Oscillometry (IOS) from baseline |
| Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R) | 1 month | Evolution of CFQ-R total score (0-100) from baseline |
| Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire | 1 month | Evolution of respiratory score (0-100) of CFQ-R from baseline |
| Change in Forced Expiratory Volume in 1 second (FEV1) | 1 month | Evolution of FEV1 (spirometry) from baseline |
| Change in central lung resistance | 1 month | Evolution of R20hz - Impulse Oscillometry (IOS) from baseline |
| Change in Residual Volume (RV) | 1 month | Evolution of RV (body plethysmography) from baseline |
| Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume | 1 month | Evolution of MEF 25, 50 and 75 (spirometry) from baseline |
| Change in Mean Mid Expiratory Flow (MMEF) | 1 month | Evolution of MMEF (spirometry) from baseline |
| Change in lung clearance index (LCI) | 1 month | Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline |
| Pulmonary exacerbation | 1 month | Rate of pulmonary exacerbation |
| Adverse events | 1 month | Rate of adverse events related or not related to intervention |
| Change in Forced Vital Capacity (FVC) | 1 month | Evolution of FVC (spirometry) from baseline |
Countries
Poland
Outcome results
None listed