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

• ClinicalTrials.gov Identifier: NCT03299231
• Recruitment Status: Recruiting
• First Posted: October 3, 2017
• Last Update Posted: January 13, 2020
• Sponsor: Ain Shams University
• Collaborator: Trudell Medical International
• Information provided by (Responsible Party): Hesham Raafat, Ain Shams University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Device: OPEP Aerobika; Device: OPEP Aerobika Sham device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Randomization carried by a third party not involved in the study.
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: January 22, 2018
• Estimated Primary Completion Date: July 2020
• Estimated Study Completion Date: July 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. percent change of Forced expiratory volume in first second (FEV1) [ Time Frame: at 12 weeks after hospital discharge ]
   change in volume of air expired forcefully in first second of expiration
2. percent change of Forced vital capacity (FVC) [ Time Frame: at 12 weeks after hospital discharge ]
   change in total volume of air expired forcefully
3. percent change of six minutes walking distance (6MWD) [ Time Frame: at 12 weeks after hospital discharge ]
   distance in meters a subject walk within 6 minutes

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Hesham H Raafat, M.D.; +966592542751; hesham.raafat@med.asu.edu.eg

Contact: Gihan Elassal, M.D.; +201001130465; gelassal2006@gmail.com

Locations

Egypt

Ain Shams University Hospital; Recruiting

Cairo, Egypt

Contact: Ragi M Ghali, MsC +201063340684 ragi.ghali@med.asu.edu.eg

Contact: Gihan H Alassal, M.D. +201001130465 gelassal2006@gmail.com

Principal Investigator: Hesham H Raafat, M.D.

Sub-Investigator: Yasser Mostafa, M.D.

Sponsors and Collaborators

Ain Shams University

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

More Information

• Responsible Party: Hesham Raafat, Ass. Professor of chest medicine, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03299231
• Other Study ID Numbers: FMASU P56/2017
• First Posted: October 3, 2017
• Last Update Posted: January 13, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hesham Raafat, Ain Shams University:

COPD; acute exacerbation; OPEP

Additional relevant MeSH terms:

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Lung Diseases, Obstructive