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

NCT06017739 | Recruiting DMC

• 1 other identifier: 759del07/08/23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Copd; Bronchiectasis Adult

Keywords

EFA; HIGH FLOW; BRONCHIECTASIS; COPD; HYPERSECRETION

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• FEV 1 (Forced Expiratory Volume)

  "Day0", "Week6", Week13"

• Exacerbations

  "Day0", "Week6", Week13"

• Inspiratory Capacity

  "Day0", "Week6", Week13"

• 6 minutes walking test

  "Day0", "Week6", Week13"

• Saint George Respiratory Questionnaire

  "Day0", "Week6", Week13"

Study Arms (2)

Expiratory Flow Accelerator

EXPERIMENTAL

Patients for 6 weeks use the Expiratory Flow Accelerator Technology

Device: Bronchial Clearance A

Expiratory Flow Accelerator + HIGH FLOW Technology

EXPERIMENTAL

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

Device: Bronchial Clearance B

Interventions

Bronchial Clearance A DEVICE

EFA technology: the patient has to breathe at tidal volume by a mouthpiece at level 5 for half an hour twice a day.

Expiratory Flow Accelerator

Bronchial Clearance B DEVICE

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.

Expiratory Flow Accelerator + HIGH FLOW Technology

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale della Valle Olona: lead

Study Sites (1)

Marianna Messina

Somma Lombardo, Varese, 21019, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiectasis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases

Study Officials

• Marianna Messina

  ASST Valle Olona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianna Messina

CONTACT

+393356509059; annamessina.mm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: the two arms of the study are: 1. EFA / EFA + High Flow 2. EFA + High Flow / EFA patients are randomly assigned to one of two groups

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 30, 2023
• Study Start: October 9, 2023
• Primary Completion: July 18, 2024
• Study Completion: January 18, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)