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

Not Applicable

Recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: OPEP Aerobika; Device: OPEP Aerobika Sham device

• Registration Number: NCT03299231
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Study Start: 2018-01-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-07
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobika	OPEP 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.
Sham device	OPEP Aerobika 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

Primary Outcome Measures

Name	Time	Method
percent change of Forced expiratory volume in first second (FEV1)	at 12 weeks after hospital discharge	change in volume of air expired forcefully in first second of expiration
percent change of Forced vital capacity (FVC)	at 12 weeks after hospital discharge	change in total volume of air expired forcefully
percent change of six minutes walking distance (6MWD)	at 12 weeks after hospital discharge	distance in meters a subject walk within 6 minutes

Secondary Outcome Measures

Name	Time	Method
severe COPD exacerbation	12 weeks after discharge	exacerbation of COPD need hospitalization
hospital stay	first day of hospital admission to day of hospital discharge up to 12 weeks	measured in days of hospital stay
hospital readmission	4 weeks after discharge	admission to hospital after 30 days of discharge due to COPD exacerbation
Moderate COPD exacerbation	12 weeks after discharge	exacerbation of COPD need additional treatment as antibiotics and/or steroids
change in score of shortness of breath	12 weeks after hospital discharge	measure by baseline and transitional dyspnea index
change in health related quality of life	12 weeks after hospital discharge	measured by Saint George Respiratory Questionnaire

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt