Expiratory Flow Accelerator (Efa) vs Efa + High Flow in Chronic COPD and Bronchiectasis

Azienda Socio Sanitaria Territoriale della Valle Olona

Status: Enrolling

Conditions: Bronchiectasis Adult; Copd

Treatments: Device: Bronchial Clearance B; Device: Bronchial Clearance A

Study type: Interventional

Funder types: Other

Identifiers

NCT06017739

759del07/08/23

Details and patient eligibility

About

The aim of the study is to compare the efficacy of using EFA technology versus the combination of EFA + high flow in hypersecretory patients COPD and bronchiectasis

Full description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 13-weeks trial period: 6 weeks of one technology (EFA / EFA+ HIGH FLOW), 1- wash out week and 6- weeks of the other technology in a cross over randomized trial.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD diagnosed by spirometry
• Bronchiectasis diagnosed by CT
• 2 Exacerbation/year

Exclusion criteria

• Cystic Fibrosis
• OSAS
• Non Invasive Ventilation
• Ineffective Cough
• Exacerbation in progress
• Hemodynamic Instability
• severe heart failure

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Expiratory Flow Accelerator

Experimental group

Description:

Patients for 6 weeks use the Expiratory Flow Accelerator Technology

Treatment:

Device: Bronchial Clearance A

Expiratory Flow Accelerator + HIGH FLOW Technology

Experimental group

Description:

Patients for 6 weeks use the EFA technology and High Flow Technology

Treatment:

Device: Bronchial Clearance B