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| Name | Class |
|---|---|
| Trudell Medical International | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in health related quality of life | measured by Saint George Respiratory Questionnaire | 12 weeks after hospital discharge |
| change in score of shortness of breath | measure by baseline and transitional dyspnea index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hesham H Raafat, M.D. | Contact | +966592542751 | hesham.raafat@med.asu.edu.eg | |
| Gihan Elassal, M.D. | Contact | +201001130465 | gelassal2006@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Kushnarev | Trudell Medical International | Study Director |
| Hesham H Raafat, M.D. | Ain Shams University | Principal Investigator |
| Yasser Mostafa, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospital | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.
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Randomization carried by a third party not involved in the study.
| 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. |
|
| 12 weeks after hospital discharge |
| hospital stay | measured in days of hospital stay | 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 | 4 weeks after discharge |
| severe COPD exacerbation | exacerbation of COPD need hospitalization | 12 weeks after discharge |
| Moderate COPD exacerbation | exacerbation of COPD need additional treatment as antibiotics and/or steroids | 12 weeks after discharge |
| Ain Shams University |
| Study Director |
| Brian W Carlin | West Penn Allegheny Health System | Study Director |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |