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

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ClinicalTrials.gov Identifier: NCT03299231
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Trudell Medical International
Information provided by (Responsible Party):
Hesham Raafat, 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.

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 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 : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299231


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: Yehia R Yousef, MsC    +201289028051    dr_yehiary@yahoo.com   
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

Responsible Party: Hesham Raafat, Ass. Professor of chest medicine, Ain Shams University
ClinicalTrials.gov Identifier: NCT03299231     History of Changes
Other Study ID Numbers: FMASU P56/2017
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
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
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes