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

NCT03299231 | Recruiting DMC

• 1 other identifier: FMASU P56/2017
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; acute exacerbation; OPEP

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• change in health related quality of life

  12 weeks after hospital discharge

• change in score of shortness of breath

  12 weeks after hospital discharge

• hospital stay

  first day of hospital admission to day of hospital discharge up to 12 weeks

• hospital readmission

  4 weeks after discharge

• severe COPD exacerbation

  12 weeks after discharge

Study Arms (2)

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.

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

Device: OPEP Aerobika Sham device

Interventions

OPEP Aerobika DEVICE

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.

Aerobika

OPEP Aerobika Sham device DEVICE

The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.

Sham device

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Trudell Medical International: collaborator

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vladimir Kushnarev

  Trudell Medical International

  STUDY DIRECTOR

• Hesham H Raafat, M.D.

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Yasser Mostafa, M.D.

  Ain Shams University

  STUDY DIRECTOR

• Brian W Carlin

  West Penn Allegheny Health System

  STUDY DIRECTOR

Central Study Contacts

Hesham H Raafat, M.D.

CONTACT

+966592542751; hesham.raafat@med.asu.edu.eg

Gihan Elassal, M.D.

CONTACT

+201001130465; gelassal2006@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization carried by a third party not involved in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor of chest medicine

Model Details: Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 3, 2017
• Study Start: January 22, 2018
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)