Pulmonary Disease, Chronic ObstructiveSIMPLENCT03299231
Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing OPEP Aerobika in people with Pulmonary Disease, Chronic Obstructive, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- OPEP Aerobika
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2018to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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, ...
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo
Ragi M Ghali, MsC, +201063340684, ragi.ghali@med.asu.edu.eg
Gihan H Alassal, M.D., +201001130465, gelassal2006@gmail.com
About this study
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)
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- OPEP Aerobika, OPEP Aerobika Sham device
- Keywords
- COPD, acute exacerbation, OPEP
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPEP AerobikaDevice
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 deviceDevice
The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.
| Study group | Role | What they receive |
|---|---|---|
| Aerobika | Active comparator | 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. Receives: Device: OPEP Aerobika |
| Sham device | Sham comparator | 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 Receives: Device: OPEP Aerobika Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent change of Forced expiratory volume in first second (FEV1)
change in volume of air expired forcefully in first second of expiration
Measured: at 12 weeks after hospital discharge
percent change of Forced vital capacity (FVC)
change in total volume of air expired forcefully
Measured: at 12 weeks after hospital discharge
percent change of six minutes walking distance (6MWD)
distance in meters a subject walk within 6 minutes
Measured: at 12 weeks after hospital discharge
Secondary outcomes (6)
change in health related quality of life
measured by Saint George Respiratory Questionnaire
Measured: 12 weeks after hospital discharge
change in score of shortness of breath
measure by baseline and transitional dyspnea index
Measured: 12 weeks after hospital discharge
hospital stay
measured in days of hospital stay
Measured: 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
Measured: 4 weeks after discharge
severe COPD exacerbation
exacerbation of COPD need hospitalization
Measured: 12 weeks after discharge
Moderate COPD exacerbation
exacerbation of COPD need additional treatment as antibiotics and/or steroids
Measured: 12 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start22 Jan 2018
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Trudell Medical International
- Responsible party
- Principal investigator, Hesham Raafat, Ain Shams University
- Investigators
- Vladimir Kushnarev, Study director, Trudell Medical InternationalHesham H Raafat, M.D., Principal investigator, Ain Shams UniversityYasser Mostafa, M.D., Study director, Ain Shams UniversityBrian W Carlin, Study director, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299231
- Sponsor's protocol ID
- FMASU P56/2017
- Acronym
- SIMPLE
- Status last verified
- May 2024
- First submitted
- 22 Sep 2017
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03299231
- Acronym / sponsor ID
- SIMPLE / FMASU P56/2017
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, acute exacerbation, OPEP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Trudell Medical International
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.
| Arm | Type | Receives |
|---|---|---|
| Aerobika | Active comparator | Device: OPEP AerobikaGroup 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. |
| Sham device | Sham comparator | Device: OPEP Aerobika Sham deviceGroup 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPEP AerobikaPrevious 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. | Device | Aerobika |
| OPEP Aerobika Sham deviceThe same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm. | Device | Sham device |
Primary outcome
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
percent change of Forced vital capacity (FVC)
Time frame: at 12 weeks after hospital discharge
change in total volume of air expired forcefully
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
6 secondary outcomes
change in health related quality of life
Time frame: 12 weeks after hospital discharge
change in score of shortness of breath
Time frame: 12 weeks after hospital discharge
hospital stay
Time frame: first day of hospital admission to day of hospital discharge up to 12 weeks
hospital readmission
Time frame: 4 weeks after discharge
severe COPD exacerbation
Time frame: 12 weeks after discharge
Moderate COPD exacerbation
Time frame: 12 weeks after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Kushnarev study director
Trudell Medical International
Hesham H Raafat, M.D. principal investigator
Ain Shams University
Yasser Mostafa, M.D. study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPEP Aerobika in people with Pulmonary Disease, Chronic Obstructive, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hesham H Raafat, M.D. (+966592542751, hesham.raafat@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent change of Forced expiratory volume in first second (FEV1) (time frame: at 12 weeks after hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.