RecruitingNot ApplicableNCT03299231

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)


Sponsor

Ain Shams University

Enrollment

160 participants

Start Date

Jan 22, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a special breathing device — called an oscillating positive expiratory pressure (OPEP) device — helps patients with severe COPD (chronic obstructive pulmonary disease) recover faster when they are hospitalized for a flare-up of their condition. **You may be eligible if...** - You have severe COPD (stages 3 or 4) confirmed by breathing tests - You are being admitted to hospital due to a COPD flare-up - You are a current or former smoker - You are willing and able to give written consent **You may NOT be eligible if...** - Your COPD is not severe enough to meet the study criteria - You are not well enough to use the device - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOPEP 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.

DEVICEOPEP 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

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NCT03299231


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