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

Copd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017739
• Other study ID #: 759del07/08/23
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: January 18, 2025

Study information

• Verified date: February 2024
• Source: Azienda Socio Sanitaria Territoriale della Valle Olona
• Contact: Marianna Messina
• Phone: +393356509059
• Email: annamessina.mm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 18, 2025
• Est. primary completion date: July 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult
• Copd

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Marianna Messina	Somma Lombardo	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale della Valle Olona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough Severity	Visual Analogic Scale (0=not severe cough;10=very severe cough)	"Day0", "Week6", Week13"
Primary	Expectoration Difficulty	Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty)	"Day0", "Week6", Week13"
Secondary	FEV 1 (Forced Expiratory Volume)	Airway obstruction index measured by spirometry	"Day0", "Week6", Week13"
Secondary	Exacerbations	number of exacerbation/ year	"Day0", "Week6", Week13"
Secondary	Inspiratory Capacity	air trapping index measured by spirometry	"Day0", "Week6", Week13"
Secondary	6 minutes walking test	index of cardiorespiratory function in activities of daily living	"Day0", "Week6", Week13"
Secondary	Saint George Respiratory Questionnaire	quality of life	"Day0", "Week6", Week13"
Secondary	Medical Research Council mMRC	dyspnea perception (0 no dyspnea, 4 very important dyspnea)	"Day0", "Week6", Week13"
Secondary	SpO2 (Oxygen Saturation by Pulse Oximetry)	blood oxygen saturation	"Day0", "Week6", Week13"