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

Hypersecreting Patients (COPD And/or Bronchiectasic) Comparing 2 Technologies: Efa vs Efa + High Flow

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

Study Overview

• Status: Recruiting
• Conditions: Copd; Bronchiectasis Adult
• Intervention / Treatment: Device: Bronchial Clearance A; Device: Bronchial Clearance B

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianna Messina; Phone Number: +393356509059; Email: annamessina.mm@gmail.com

Study Locations

• Italy
  • Varese
    • Somma Lombardo, Varese, Italy, 21019
      • Recruiting
      • Marianna Messina
      • Contact: Marianna Messina; Phone Number: +393356509059; Email: marianna.messina@asst-valleolona.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expiratory Flow Accelerator; Patients for 6 weeks use the Expiratory Flow Accelerator Technology	Device: Bronchial Clearance A; EFA technology: the patient has to breathe at tidal volume by a mouthpiece at level 5 for half an hour twice a day.
Experimental: Expiratory Flow Accelerator + HIGH FLOW Technology; Patients for 6 weeks use the EFA technology and High Flow Technology	Device: Bronchial Clearance B; High Flow Technology: patient has to wear nasal cannula and breathe his nose for one hour twice a day. After he has to use EFA technology level 5 for half an hour twice a day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale della Valle Olona
• Investigators: Principal Investigator: Marianna Messina, ASST Valle Olona

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): July 18, 2024
• Study Completion (Estimated): January 18, 2025

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COPD; EFA; BRONCHIECTASIS; HIGH FLOW; HYPERSECRETION
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 759del07/08/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No