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

Sponsor

Azienda Socio Sanitaria Territoriale della Valle Olona (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06017739

Collaborator

(none)

Enrollment

Location

Arms

16.3

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Copd Bronchiectasis Adult	Device: Bronchial Clearance A Device: Bronchial Clearance B	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

the two arms of the study are: EFA / EFA + High Flow EFA + High Flow / EFA patients are randomly assigned to one of two groupsthe two arms of the study are: EFA / EFA + High Flow EFA + High Flow / EFA patients are randomly assigned to one of two groups

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 11, 2023

Anticipated Primary Completion Date :

Jul 18, 2024

Anticipated Study Completion Date :

Jan 18, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

FEV 1 (Forced Expiratory Volume) ["Day0", "Week6", Week13"]
Airway obstruction index measured by spirometry
Exacerbations ["Day0", "Week6", Week13"]
number of exacerbation/ year
Inspiratory Capacity ["Day0", "Week6", Week13"]
air trapping 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)
SpO2 (Oxygen Saturation by Pulse Oximetry) ["Day0", "Week6", Week13"]
blood oxygen saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marianna Messina	Fagnano Olona	Varese	Italy	21054

Sponsors and Collaborators

Azienda Socio Sanitaria Territoriale della Valle Olona

Investigators

Principal Investigator: Marianna Messina, ASST Valle Olona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MARIANNA MESSINA, Principal Investigator, Azienda Socio Sanitaria Territoriale della Valle Olona

ClinicalTrials.gov Identifier:

NCT06017739

Other Study ID Numbers:

759del07/08/23

First Posted:

Aug 30, 2023

Last Update Posted:

Sep 8, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by MARIANNA MESSINA, Principal Investigator, Azienda Socio Sanitaria Territoriale della Valle Olona

Additional relevant MeSH terms:

Bronchiectasis

Study Results

No Results Posted as of Sep 8, 2023