Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT03299231

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

Led by Ain Shams University · Updated on 2024-05-23

160

Participants Needed

1

Research Sites

349 weeks

Total Duration

On this page

Sponsors

A

Ain Shams University

Lead Sponsor

T

Trudell Medical International

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • COPD patients with stage 3 or 4 disease by GOLD 2016 guidelines, with post-bronchodilator FEV1/FVC less than 70% and FEV1 less than 50%, experiencing exacerbations needing hospital admission
  • Current or former smokers
  • Able and willing to give informed consent and understand how to use the bronchial clearing device
  • Able to perform spirometry effectively
  • Willing to follow the prescribed management plan including systemic steroids if needed
Not Eligible

You will not qualify if you...

  • Other obstructive lung diseases or patients not meeting COPD diagnosis criteria
  • Non-smokers
  • Major organ dysfunction from cardiac (including severe pulmonary hypertension), kidney, or liver disease (excluding diabetes, high blood pressure, or obesity)
  • Presence of lobar pneumonia
  • Suspicion of lung cancer
  • Complications such as pneumothorax, pulmonary embolism, heart attack, stroke during admission or stay
  • Unable or unwilling to provide informed consent
  • Unable to use the bronchial clearing device
  • Unable to perform spirometry
  • Unable or unwilling to follow the management plan or study protocol
  • Regular use of oral steroids or non-selective beta blockers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ain Shams University Hospital

Cairo, Egypt

Actively Recruiting

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Research Team

H

Hesham H Raafat, M.D.

CONTACT

G

Gihan Elassal, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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