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

Study Overview
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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.

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

Conditions
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Copd, Bronchiectasis Adult

Intervention / Treatment
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* Device: Bronchial Clearance A
* Device: Bronchial Clearance B


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expiratory Flow Accelerator<br>Patients for 6 weeks use the Expiratory Flow Accelerator Technology | Device: Bronchial Clearance A<br>* EFA technology: the patient has to breathe at tidal volume by a mouthpiece at level 5 for half an hour twice a day.<br>|
| Experimental: Expiratory Flow Accelerator + HIGH FLOW Technology<br>Patients for 6 weeks use the EFA technology and High Flow Technology | Device: Bronchial Clearance B<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV 1 (Forced Expiratory Volume) | Airway obstruction index measured by spirometry | Day0, Week6, Week13 | 
| Exacerbations | number of exacerbation/ year | Day0, Week6, Week13 | 
| Inspiratory Capacity | air trapping index measured by spirometry | Day0, Week6, Week13 | 
| 6 minutes walking test | index of cardiorespiratory function in activities of daily living | Day0, Week6, Week13 | 
| Saint George Respiratory Questionnaire | quality of life | Day0, Week6, Week13 | 
| Medical Research Council mMRC | dyspnea perception (0 no dyspnea, 4 very important dyspnea) | Day0, Week6, Week13 | 
| SpO2 (Oxygen Saturation by Pulse Oximetry) | blood oxygen saturation | Day0, Week6, Week13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EFA, HIGH FLOW, BRONCHIECTASIS, COPD, HYPERSECRETION