Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Cystic Fibrosis in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084041
• Other study ID #: HOMECARE_CF
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: February 2021
• Source: Physio-Assist
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Clearance Impairment
• Cystic Fibrosis
• Cystic Fibrosis in Children
• Fibrosis

Intervention

Device:
• Simeox
Airway clearance device

Other:
• CCPT
Conventional chest physiotherapy

Locations

Country	Name	City	State
Poland	IMiD	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Physio-Assist

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total lung resistance	Evolution of R5hz - Impulse Oscillometry (IOS) from baseline	1 month
Secondary	Change in central lung resistance	Evolution of R20hz - Impulse Oscillometry (IOS) from baseline	1 month
Secondary	Change in peripheral lung resistance	Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline	1 month
Secondary	Change in total lung reactance	Evolution of X5hz -Impulse Oscillometry (IOS) from baseline	1 month
Secondary	Change in area of reactance (AX)	Evolution of AX -Impulse Oscillometry (IOS) from baseline	1 month
Secondary	Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R)	Evolution of CFQ-R total score (0-100) from baseline	1 month
Secondary	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
Secondary	Change in Forced Expiratory Volume in 1 second (FEV1)	Evolution of FEV1 (spirometry) from baseline	1 month
Secondary	Change in Forced Vital Capacity (FVC)	Evolution of FVC (spirometry) from baseline	1 month
Secondary	Change in Residual Volume (RV)	Evolution of RV (body plethysmography) from baseline	1 month
Secondary	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
Secondary	Change in Mean Mid Expiratory Flow (MMEF)	Evolution of MMEF (spirometry) from baseline	1 month
Secondary	Change in lung clearance index (LCI)	Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline	1 month
Secondary	Pulmonary exacerbation	Rate of pulmonary exacerbation	1 month
Secondary	Adverse events	Rate of adverse events related or not related to intervention	1 month