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

Ain Shams University

Status: Enrolling

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: OPEP Aerobika Sham device; Device: OPEP Aerobika

Study type: Interventional

Funder types: Other

Identifiers

NCT03299231

FMASU P56/2017

Details and patient eligibility

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Aerobika

Active Comparator group

Description:

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.

Treatment:

Device: OPEP Aerobika

Sham device

Sham Comparator group

Description:

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

Treatment:

Device: OPEP Aerobika Sham device