Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Sputum production increases in acute exacerbation of COPD, both in amount and consistency. It increases airways obstruction and hence delays improvement and prolongs hospital stay. oscillating positive expiratory pressure (OPEP) devices were extensively studied in cystic fibrosis and bronchiectasis. Only seldom studied in chronic bronchitis. This study aims to measure the effects of mucous clearing device in hospitalized patients with acute exacerbation of COPD.

Detailed Description
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In this study, investigators will investigate the change of objective measurements of lung functions and exercise capacity in addition to subjective measures of quality of life.

Official Title
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Oscillating Positive Expiratory Pressure Device for Mucous Clearing in Severe Exacerbation of COPD Requiring Hospitalization Targeting Outcome: A Randomized, Double Blind, Sham Controlled Trial (SIMPLE)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: OPEP Aerobika
* Device: OPEP Aerobika Sham device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD patients, stages 3-4 according to GOLD guidelines 2016, with post bronchodilator FEV1/FVC < 70% of predicted and FEV1 < 50% with exacerbations necessitates hospital admission. Smokers or Ex-smokers. Able and willing to provide informed signed consent. Able and understanding the correct use of the bronchial clearing device. Able to perform effectively spirometry. Able and willing to receive the management plane as indicated including systemic steroids if seemed necessary. Exclusion Criteria: Other obstructive pulmonary diseases or those do not fulfill the criteria of COPD diagnosis. Nonsmokers. Presence of major comorbidity causing organ dysfunction as cardiac (including severe pulmonary hypertension), renal, or liver impairment (not including diabetes, arterial hypertension, or obesity). Presence of lobar pneumonia. Suspicion of bronchogenic malignancy. Any other complication either at admission or during hospital stay as pneumothorax, pulmonary embolism, myocardial infarction, acute coronary syndrome, cerebrovascular accidents, ... Patients unable or not willing to provide informed signed consent. Patients unable to use the bronchial clearing device. Patients unable to perform spirometry. Patients unable or not willing to comply to the management plan or the study protocol. Patients receiving regular oral steroids or non-selective beta blockers.

Ages Eligible for Study
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Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobika<br>Group of participants with COPD, hospitalized for severe exacerbation and using the active oscillating positive expiratory pressure device (OPEP). The device is a hand held one. Used mostly in subjects with bronchiectasis for mucus clearing. Estimated number of subjects in this arm is 80. The device has an adjustable resistance which will be set by a health care provider in the study team. The device is to be used three times daily from 10 to 20 minutes according to subject's effort. | Device: OPEP Aerobika<br>* Previous studies of OPEP device shows preliminary benefit in subjects with COPD. No serious adverse events were recorded in previous studies. The device is FDA registered.<br>|
| Sham Comparator: Sham device<br>Group of participants using the same looking device which is devoid from nebulizer port valve so it is not functioning (sham device). The sham arm is a control arm. It will be used as the active comparator three times daily for 10 to 20 minutes according to subject's effort | Device: OPEP Aerobika Sham device<br>* The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent change of Forced expiratory volume in first second (FEV1) | change in volume of air expired forcefully in first second of expiration | at 12 weeks after hospital discharge | 
| percent change of Forced vital capacity (FVC) | change in total volume of air expired forcefully | at 12 weeks after hospital discharge | 
| percent change of six minutes walking distance (6MWD) | distance in meters a subject walk within 6 minutes | at 12 weeks after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in health related quality of life | measured by Saint George Respiratory Questionnaire | 12 weeks after hospital discharge | 
| change in score of shortness of breath | measure by baseline and transitional dyspnea index | 12 weeks after hospital discharge | 
| hospital stay | measured in days of hospital stay | first day of hospital admission to day of hospital discharge up to 12 weeks | 
| hospital readmission | admission to hospital after 30 days of discharge due to COPD exacerbation | 4 weeks after discharge | 
| severe COPD exacerbation | exacerbation of COPD need hospitalization | 12 weeks after discharge | 
| Moderate COPD exacerbation | exacerbation of COPD need additional treatment as antibiotics and/or steroids | 12 weeks after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, acute exacerbation, OPEP