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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: OPEP Aerobika; Device: OPEP Aerobika Sham device

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hesham H Raafat, M.D.; Phone Number: +966592542751; Email: hesham.raafat@med.asu.edu.eg
• Study Contact Backup: Name: Gihan Elassal, M.D.; Phone Number: +201001130465; Email: gelassal2006@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University Hospital
    • Contact: Ragi M Ghali, MsC; Phone Number: +201063340684; Email: ragi.ghali@med.asu.edu.eg
    • Contact: Gihan H Alassal, M.D.; Phone Number: +201001130465; Email: gelassal2006@gmail.com
    • Principal Investigator: Hesham H Raafat, M.D.
    • Sub-Investigator: Yasser Mostafa, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Sham Comparator: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
percent change of Forced vital capacity (FVC)	change in total volume of air expired forcefully	at 12 weeks after hospital discharge
percent change of six minutes walking distance (6MWD)	distance in meters a subject walk within 6 minutes	at 12 weeks after hospital discharge

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Trudell Medical International
• Investigators: Study Director: Vladimir Kushnarev, Trudell Medical International; Principal Investigator: Hesham H Raafat, M.D., Ain Shams University; Study Director: Yasser Mostafa, M.D., Ain Shams University; Study Director: Brian W Carlin, West Penn Allegheny Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COPD; acute exacerbation; OPEP
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: FMASU P56/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No