Using a device to help clear mucus in patients with severe COPD exacerbations

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)

This study tests if a special device can help hospitalized patients with severe COPD clear mucus and feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Ain Shams University (other)
• Locations: 1 site (Cairo)
• Trial ID: NCT03299231 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of oscillating positive expiratory pressure (OPEP) devices on hospitalized patients experiencing acute exacerbations of chronic obstructive pulmonary disease (COPD). The research aims to measure changes in lung function and exercise capacity, as well as subjective quality of life assessments. Participants will use either the OPEP Aerobika device or a sham device to evaluate the effectiveness of mucus clearance in improving their condition. The study focuses on patients with severe COPD who require hospitalization due to exacerbations.

Who should consider this trial

Good fit: Ideal candidates are hospitalized COPD patients in stages 3-4 with significant airflow obstruction and exacerbations requiring admission.

Not a fit: Patients with other obstructive pulmonary diseases, nonsmokers, or those with major comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved mucus clearance and shorter hospital stays for patients with acute exacerbations of COPD.

How similar studies have performed: Previous studies have shown the effectiveness of OPEP devices in other respiratory conditions, but their application in chronic bronchitis is less explored.

Eligibility criteria

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.

Where this trial is running

Cairo

• Ain Shams University Hospital — Cairo, Egypt (RECRUITING)

Study contacts

• Principal investigator: Hesham H Raafat, M.D. — Ain Shams University
• Study coordinator: Hesham H Raafat, M.D.

Conditions: Pulmonary Disease, Chronic Obstructive, COPD, acute exacerbation, OPEP