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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

Pulmonary Disease, Chronic Obstructive

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

Inclusion Criteria5

  • 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 Criteria11

  • 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.

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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