Clinical trial NCT03299231: Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: Oscillating Positive Expiratory Pressure Device for Mucous Clearing in Severe Exacerbation of COPD Requiring Hospitalization Targeting Outcome: A Randomized, Double Blind, Sham Controlled Trial (SIMPLE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
acute exacerbation
OPEP
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Trudell Medical International
First posted: 2017-10-03
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: percent change of Forced expiratory volume in first second (FEV1)
timeFrame: at 12 weeks after hospital discharge
measure: percent change of Forced vital capacity (FVC)
timeFrame: at 12 weeks after hospital discharge
measure: percent change of six minutes walking distance (6MWD)
timeFrame: at 12 weeks after hospital discharge
Secondary outcomes:
measure: change in health related quality of life
timeFrame: 12 weeks after hospital discharge
measure: change in score of shortness of breath
timeFrame: 12 weeks after hospital discharge
measure: hospital stay
timeFrame: first day of hospital admission to day of hospital discharge up to 12 weeks
measure: hospital readmission
timeFrame: 4 weeks after discharge
measure: severe COPD exacerbation
timeFrame: 12 weeks after discharge
measure: Moderate COPD exacerbation
timeFrame: 12 weeks after discharge
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Trudell Medical International
name: Vladimir Kushnarev
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Hesham H Raafat, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Yasser Mostafa, M.D.
role: STUDY_DIRECTOR
affiliation: West Penn Allegheny Health System
name: Brian W Carlin
role: STUDY_DIRECTOR
References: