Clinical trial NCT04084041: Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis
Official title: Efficacy of the Simeox Airway Clearance Technology in the Treatment of Children With Clinically Stable Cystic Fibrosis- Cross-over Study With Randomization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis in Children
Airway Clearance Impairment
Keywords: Airway clearance technique
Lead sponsor: Physio-Assist
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in total lung resistance
timeFrame: 1 month
Secondary outcomes:
measure: Change in central lung resistance
timeFrame: 1 month
measure: Change in peripheral lung resistance
timeFrame: 1 month
measure: Change in total lung reactance
timeFrame: 1 month
measure: Change in area of reactance (AX)
timeFrame: 1 month
measure: Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R)
timeFrame: 1 month
measure: Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire
timeFrame: 1 month
measure: Change in Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 1 month
measure: Change in Forced Vital Capacity (FVC)
timeFrame: 1 month
measure: Change in Residual Volume (RV)
timeFrame: 1 month
measure: Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume
timeFrame: 1 month
measure: Change in Mean Mid Expiratory Flow (MMEF)
timeFrame: 1 month
measure: Change in lung clearance index (LCI)
timeFrame: 1 month
measure: Pulmonary exacerbation
timeFrame: 1 month
measure: Adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: IMiD
Study officials:
affiliation: IMiD
name: Dorota Sands, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sands D, Walicka-Serzysko K, Milczewska J, Postek M, Jeneralska N, Cichocka A, Siedlecka E, Borawska-Kowalczyk U, Morin L. Efficacy of the Simeox(R) Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial. Children (Basel). 2023 Jan 23;10(2):204. doi: 10.3390/children10020204.