NCT04096664

Home Airway Clearance in CF Patients

Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Prospective, Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Physio-Assist · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, post-care, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.

Conditions

• Pulmonary Cystic Fibrosis

Interventions

Type	Name	Description
DEVICE	SIMEOX	Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX

Timeline

• Start date: 2020-03-10
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2019-09-20
• Last updated: 2025-06-11

Locations

20 sites across 1 country: France