NCT04084041

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Physio-Assist · Industry
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Simeox	Airway clearance device
OTHER	CCPT	Conventional chest physiotherapy

Timeline

• Start date: 2019-09-10
• Primary completion: 2021-01-31
• Completion: 2021-02-15
• First posted: 2019-09-10
• Last updated: 2025-09-24

Locations

1 site across 1 country: Poland