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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— SIMPLE  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299231
• Other study ID #: FMASU P56/2017
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: Hesham H Raafat, M.D.
• Phone: +966592542751
• Email: hesham.raafat[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Trudell Medical International

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent change of Forced expiratory volume in first second (FEV1)	change in volume of air expired forcefully in first second of expiration	at 12 weeks after hospital discharge
Primary	percent change of Forced vital capacity (FVC)	change in total volume of air expired forcefully	at 12 weeks after hospital discharge
Primary	percent change of six minutes walking distance (6MWD)	distance in meters a subject walk within 6 minutes	at 12 weeks after hospital discharge
Secondary	change in health related quality of life	measured by Saint George Respiratory Questionnaire	12 weeks after hospital discharge
Secondary	change in score of shortness of breath	measure by baseline and transitional dyspnea index	12 weeks after hospital discharge
Secondary	hospital stay	measured in days of hospital stay	first day of hospital admission to day of hospital discharge up to 12 weeks
Secondary	hospital readmission	admission to hospital after 30 days of discharge due to COPD exacerbation	4 weeks after discharge
Secondary	severe COPD exacerbation	exacerbation of COPD need hospitalization	12 weeks after discharge
Secondary	Moderate COPD exacerbation	exacerbation of COPD need additional treatment as antibiotics and/or steroids	12 weeks after discharge