Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
COPD, acute exacerbation, OPEP
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.
Interventions
DEVICEOPEP 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.
DEVICEOPEP Aerobika Sham device
The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.
Sponsors
Trudell Medical International
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Randomization carried by a third party not involved in the study.
Intervention model description
Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percent change of Forced expiratory volume in first second (FEV1) | 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) | at 12 weeks after hospital discharge | change in total volume of air expired forcefully |
| percent change of six minutes walking distance (6MWD) | at 12 weeks after hospital discharge | distance in meters a subject walk within 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hospital readmission | 4 weeks after discharge | admission to hospital after 30 days of discharge due to COPD exacerbation |
| change in health related quality of life | 12 weeks after hospital discharge | measured by Saint George Respiratory Questionnaire |
| Moderate COPD exacerbation | 12 weeks after discharge | exacerbation of COPD need additional treatment as antibiotics and/or steroids |
| severe COPD exacerbation | 12 weeks after discharge | exacerbation of COPD need hospitalization |
| change in score of shortness of breath | 12 weeks after hospital discharge | measure by baseline and transitional dyspnea index |
| hospital stay | first day of hospital admission to day of hospital discharge up to 12 weeks | measured in days of hospital stay |
Countries
Egypt
Contacts
Primary ContactHesham H Raafat, M.D.
Backup ContactGihan Elassal, M.D.
Outcome results
None listed