Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

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

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 Overview

• Status: Completed
• Conditions: Cystic Fibrosis in Children; Airway Clearance Impairment
• Intervention / Treatment: Device: Simeox; Other: CCPT

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • IMiD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device; Device group	Device: Simeox; Airway clearance device; Other: CCPT; Conventional chest physiotherapy
ACTIVE_COMPARATOR: Conventional chest physiotherapy; Control group	Device: Simeox; Airway clearance device; Other: CCPT; Conventional chest physiotherapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Physio-Assist
• Investigators: Principal Investigator: Dorota Sands, MD, PhD, IMiD

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2019
• Primary Completion (ACTUAL): January 31, 2021
• Study Completion (ACTUAL): February 15, 2021

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Airway clearance technique
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: HOMECARE_CF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No