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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
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.
Ain Shams University Hospital
Cairo, Egypt
RECRUITINGpercent 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
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Moderate COPD exacerbation
exacerbation of COPD need additional treatment as antibiotics and/or steroids
Time frame: 12 weeks after discharge