RECRUITINGINTERVENTIONAL

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

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

OPEP Aerobika

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.

DEVICE

OPEP Aerobika Sham device

The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.

Locations (1)

Ain Shams University Hospital

Cairo, Egypt