Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

NCT ID: NCT04084041

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2021-02-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Device

Device group

Group Type: EXPERIMENTAL

Simeox

Intervention Type: DEVICE

Airway clearance device

CCPT

Intervention Type: OTHER

Conventional chest physiotherapy

Conventional chest physiotherapy

Control group

Group Type: ACTIVE_COMPARATOR

Simeox

Intervention Type: DEVICE

Airway clearance device

CCPT

Intervention Type: OTHER

Conventional chest physiotherapy

Interventions

Simeox

Airway clearance device

Intervention Type: DEVICE

CCPT

Conventional chest physiotherapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Physio-Assist

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorota Sands, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IMiD

Locations

IMiD

Warsaw, , Poland

Countries

Poland

References

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.

Reference Type: RESULT

PMID: 36832333 (View on PubMed)

Other Identifiers

HOMECARE_CF

Identifier Type: -

Identifier Source: org_study_id