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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Suspended
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
OPEP Aerobika
OPEP Aerobika Sham device
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, acute exacerbation, OPEP

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Aerobika

Sham device

Arm Description

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.

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

Outcomes

Primary Outcome Measures

percent change of Forced expiratory volume in first second (FEV1)
change in volume of air expired forcefully in first second of expiration
percent change of Forced vital capacity (FVC)
change in total volume of air expired forcefully
percent change of six minutes walking distance (6MWD)
distance in meters a subject walk within 6 minutes

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2017
Last Updated
March 2, 2022
Sponsor
Ain Shams University
Collaborators
Trudell Medical International
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1. Study Identification

Unique Protocol Identification Number
NCT03299231
Brief Title
Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Suspended
Why Stopped
COVID 19 consequences
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Trudell Medical International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD, acute exacerbation, OPEP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Randomization carried by a third party not involved in the study.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobika
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham device
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
OPEP Aerobika
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
OPEP Aerobika Sham device
Intervention Description
The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.
Primary Outcome Measure Information:
Title
percent change of Forced expiratory volume in first second (FEV1)
Description
change in volume of air expired forcefully in first second of expiration
Time Frame
at 12 weeks after hospital discharge
Title
percent change of Forced vital capacity (FVC)
Description
change in total volume of air expired forcefully
Time Frame
at 12 weeks after hospital discharge
Title
percent change of six minutes walking distance (6MWD)
Description
distance in meters a subject walk within 6 minutes
Time Frame
at 12 weeks after hospital discharge
Secondary Outcome Measure Information:
Title
change in health related quality of life
Description
measured by Saint George Respiratory Questionnaire
Time Frame
12 weeks after hospital discharge
Title
change in score of shortness of breath
Description
measure by baseline and transitional dyspnea index
Time Frame
12 weeks after hospital discharge
Title
hospital stay
Description
measured in days of hospital stay
Time Frame
first day of hospital admission to day of hospital discharge up to 12 weeks
Title
hospital readmission
Description
admission to hospital after 30 days of discharge due to COPD exacerbation
Time Frame
4 weeks after discharge
Title
severe COPD exacerbation
Description
exacerbation of COPD need hospitalization
Time Frame
12 weeks after discharge
Title
Moderate COPD exacerbation
Description
exacerbation of COPD need additional treatment as antibiotics and/or steroids
Time Frame
12 weeks after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Kushnarev
Organizational Affiliation
Trudell Medical International
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hesham H Raafat, M.D.
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasser Mostafa, M.D.
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brian W Carlin
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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