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RECRUITING
NCT03299231
NA

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2018-01-22

Completion Date

2024-10

Last Updated

2024-05-23

Healthy Volunteers

No

Interventions

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