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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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In this study, investigators will investigate the change of objective measurements of lung functions and exercise capacity in addition to subjective measures of quality of life.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Randomization carried by a third party not involved in the study.

Study Groups

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Aerobika

Group of participants with COPD, hospitalized for severe exacerbation and using the active oscillating positive expiratory pressure device (OPEP). The device is a hand held one. Used mostly in subjects with bronchiectasis for mucus clearing. Estimated number of subjects in this arm is 80. The device has an adjustable resistance which will be set by a health care provider in the study team. The device is to be used three times daily from 10 to 20 minutes according to subject's effort.

Group Type ACTIVE_COMPARATOR

OPEP Aerobika

Intervention Type DEVICE

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.

Sham device

Group of participants using the same looking device which is devoid from nebulizer port valve so it is not functioning (sham device). The sham arm is a control arm. It will be used as the active comparator three times daily for 10 to 20 minutes according to subject's effort

Group Type SHAM_COMPARATOR

OPEP Aerobika Sham device

Intervention Type DEVICE

The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No