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

Not Applicable

Recruiting

• Conditions: Copd; Bronchiectasis Adult
• Interventions: Device: Bronchial Clearance A; Device: Bronchial Clearance B

• Registration Number: NCT06017739
• Lead Sponsor: Azienda Socio Sanitaria Territoriale della Valle Olona

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-08-30
• Study Start: 2023-10-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-07-18
• Study Completion: 2025-01-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Expiratory Flow Accelerator	Bronchial Clearance A	Patients for 6 weeks use the Expiratory Flow Accelerator Technology
Expiratory Flow Accelerator + HIGH FLOW Technology	Bronchial Clearance B	Patients for 6 weeks use the EFA technology and High Flow Technology

Primary Outcome Measures

Name	Time	Method
Expectoration Difficulty	"Day0", "Week6", Week13"	Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty)
Cough Severity	"Day0", "Week6", Week13"	Visual Analogic Scale (0=not severe cough;10=very severe cough)

Secondary Outcome Measures

Name	Time	Method
Exacerbations	"Day0", "Week6", Week13"	number of exacerbation/ year
Inspiratory Capacity	"Day0", "Week6", Week13"	air trapping index measured by spirometry
SpO2 (Oxygen Saturation by Pulse Oximetry)	"Day0", "Week6", Week13"	blood oxygen saturation
FEV 1 (Forced Expiratory Volume)	"Day0", "Week6", Week13"	Airway obstruction index measured by spirometry
6 minutes walking test	"Day0", "Week6", Week13"	index of cardiorespiratory function in activities of daily living
Saint George Respiratory Questionnaire	"Day0", "Week6", Week13"	quality of life
Medical Research Council mMRC	"Day0", "Week6", Week13"	dyspnea perception (0 no dyspnea, 4 very important dyspnea)

Trial Locations

Locations (1)

Marianna Messina; 🇮🇹 Somma Lombardo, Varese, Italy