An interventional study of OPEP Aerobika and OPEP Aerobika Sham device in Pulmonary Disease, Chronic Obstructive, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
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.
The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.
percent change of Forced expiratory volume in first second (FEV1)
change in volume of air expired forcefully in first second of expiration
Time frame: at 12 weeks after hospital discharge
percent change of Forced vital capacity (FVC)
change in total volume of air expired forcefully
Time frame: at 12 weeks after hospital discharge
percent change of six minutes walking distance (6MWD)
distance in meters a subject walk within 6 minutes
Time frame: at 12 weeks after hospital discharge
change in health related quality of life
measured by Saint George Respiratory Questionnaire
Time frame: 12 weeks after hospital discharge
change in score of shortness of breath
measure by baseline and transitional dyspnea index
Time frame: 12 weeks after hospital discharge
hospital stay
measured in days of hospital stay
Time frame: 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
Time frame: 4 weeks after discharge
severe COPD exacerbation
exacerbation of COPD need hospitalization
Time frame: 12 weeks after discharge
Moderate COPD exacerbation
exacerbation of COPD need additional treatment as antibiotics and/or steroids
Time frame: 12 weeks after discharge
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ain Shams University