Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

NCT04084041 | Completed

• 1 other identifier: HOMECARE_CF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis in Children; Airway Clearance Impairment

Keywords

Airway clearance technique

Outcome Measures

Primary Outcomes (1)

• Change in total lung resistance

  Evolution of R5hz - Impulse Oscillometry (IOS) from baseline

  1 month

Secondary Outcomes (14)

• Change in central lung resistance

  1 month

• Change in peripheral lung resistance

  1 month

• Change in total lung reactance

  1 month

• Change in area of reactance (AX)

  1 month

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

  1 month

Study Arms (2)

Device

EXPERIMENTAL

Device group

Device: Simeox; Other: CCPT

Conventional chest physiotherapy

ACTIVE COMPARATOR

Control group

Device: Simeox; Other: CCPT

Interventions

Simeox DEVICE

Airway clearance device

Conventional chest physiotherapy; Device

CCPT OTHER

Conventional chest physiotherapy

Conventional chest physiotherapy; Device

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Physio-Assist: lead

Study Sites (1)

IMiD

Warsaw, Poland

Location

Related Publications (1)

• 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.

  PMID: 36832333 RESULT

Study Officials

• Dorota Sands, MD, PhD

  IMiD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: September 10, 2019
• Primary Completion: January 31, 2021
• Study Completion: February 15, 2021
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)