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

Primary Purpose

Copd, Bronchiectasis Adult

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Bronchial Clearance A
Bronchial Clearance B
Sponsored by
Azienda Socio Sanitaria Territoriale della Valle Olona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Copd focused on measuring EFA, HIGH FLOW, BRONCHIECTASIS, COPD, HYPERSECRETION

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Marianna Messina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Expiratory Flow Accelerator

Expiratory Flow Accelerator + HIGH FLOW Technology

Arm Description

Patients for 6 weeks use the Expiratory Flow Accelerator Technology

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

Outcomes

Primary Outcome Measures

Cough Severity
Visual Analogic Scale (0=not severe cough;10=very severe cough)
Expectoration Difficulty
Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty)

Secondary Outcome Measures

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

Full Information

First Posted
August 18, 2023
Last Updated
September 28, 2023
Sponsor
Azienda Socio Sanitaria Territoriale della Valle Olona
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1. Study Identification

Unique Protocol Identification Number
NCT06017739
Brief Title
Expiratory Flow Accelerator (Efa) vs Efa + High Flow in Chronic COPD and Bronchiectasis
Official Title
Hypersecreting Patients (COPD And/or Bronchiectasic) Comparing 2 Technologies: Efa vs Efa + High Flow
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
July 18, 2024 (Anticipated)
Study Completion Date
January 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale della Valle Olona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, Bronchiectasis Adult
Keywords
EFA, HIGH FLOW, BRONCHIECTASIS, COPD, HYPERSECRETION

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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 groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Expiratory Flow Accelerator
Arm Type
Experimental
Arm Description
Patients for 6 weeks use the Expiratory Flow Accelerator Technology
Arm Title
Expiratory Flow Accelerator + HIGH FLOW Technology
Arm Type
Experimental
Arm Description
Patients for 6 weeks use the EFA technology and High Flow Technology
Intervention Type
Device
Intervention Name(s)
Bronchial Clearance A
Intervention Description
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
Intervention Name(s)
Bronchial Clearance B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cough Severity
Description
Visual Analogic Scale (0=not severe cough;10=very severe cough)
Time Frame
"Day0", "Week6", Week13"
Title
Expectoration Difficulty
Description
Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty)
Time Frame
"Day0", "Week6", Week13"
Secondary Outcome Measure Information:
Title
FEV 1 (Forced Expiratory Volume)
Description
Airway obstruction index measured by spirometry
Time Frame
"Day0", "Week6", Week13"
Title
Exacerbations
Description
number of exacerbation/ year
Time Frame
"Day0", "Week6", Week13"
Title
Inspiratory Capacity
Description
air trapping index measured by spirometry
Time Frame
"Day0", "Week6", Week13"
Title
6 minutes walking test
Description
index of cardiorespiratory function in activities of daily living
Time Frame
"Day0", "Week6", Week13"
Title
Saint George Respiratory Questionnaire
Description
quality of life
Time Frame
"Day0", "Week6", Week13"
Title
Medical Research Council mMRC
Description
dyspnea perception (0 no dyspnea, 4 very important dyspnea)
Time Frame
"Day0", "Week6", Week13"
Title
SpO2 (Oxygen Saturation by Pulse Oximetry)
Description
blood oxygen saturation
Time Frame
"Day0", "Week6", Week13"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianna Messina
Phone
+393356509059
Email
annamessina.mm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianna Messina
Organizational Affiliation
ASST Valle Olona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marianna Messina
City
Fagnano Olona
State/Province
Varese
ZIP/Postal Code
21054
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianna Messina
Phone
+393356509059
Email
marianna.messina@asst-valleolona.it

12. IPD Sharing Statement

Plan to Share IPD
No

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

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