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

NCT ID: NCT06017739

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-09

Study Completion Date

2025-01-18

Brief Summary

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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

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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.

Conditions

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Copd Bronchiectasis Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Expiratory Flow Accelerator

Patients for 6 weeks use the Expiratory Flow Accelerator Technology

Group Type EXPERIMENTAL

Bronchial Clearance A

Intervention Type 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 + HIGH FLOW Technology

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

Group Type EXPERIMENTAL

Bronchial Clearance B

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Socio Sanitaria Territoriale della Valle Olona

OTHER

Sponsor Role lead

Responsible Party

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MARIANNA MESSINA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marianna Messina

Role: PRINCIPAL_INVESTIGATOR

ASST Valle Olona

Locations

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Marianna Messina

Somma Lombardo, Varese, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Marianna Messina

Role: CONTACT

+393356509059

Facility Contacts

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Marianna Messina

Role: primary

+393356509059

Other Identifiers

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759del07/08/23

Identifier Type: -

Identifier Source: org_study_id

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