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

NCT03299231 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-05-23

No results posted yet for this study

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

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.

Sponsors & Collaborators

  • Trudell Medical International

    collaborator INDUSTRY

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Vladimir Kushnarev · Trudell Medical International

  • Hesham H Raafat, M.D. · Ain Shams University

  • Yasser Mostafa, M.D. · Ain Shams University

  • Brian W Carlin · West Penn Allegheny Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2024-07-31
Completion
2024-10-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03299231 on ClinicalTrials.gov