At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 50 enrolled
Drug / intervention
pneumatic vest +1 moredevice
Likely dose
High frequency chest wall oscillation via pneumatic vest (frequency and intensity not specified)AI-extracted
Key inclusion· 5
- ✓Physician diagnosis of COPD, chronic bronchitis, and/or emphysema
- ✓FEV1/FVC ratio ≤70%
- ✓FEV1 ≤65%
- ✓Current or former smoker with ≥20 pack-year history
Key exclusion· 3
- ✕Other lung diseases (not COPD/chronic bronchitis/emphysema)
- ✕Co-morbid illnesses such as cancer, liver disease, or cardiomyopathy
- ✕Recent chest wall or abdominal trauma or surgery that would preclude using the vest
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Sham-controlled, Double-blinded Pilot Study to Assess the Effects of High Frequency Chest Wall Oscillation (HFCWO) Therapy in Patients With Chronic Bronchitis
In Brief
A Phase 4 clinical trial evaluating pneumatic vest and placebo pneumatic vest for COPD and 2 related conditions. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The purpose of this study is to show that one form of mechanical airway clearance techniques, High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish exacerbations of COPD which will improve respiratory health status.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD, Chronic Bronchitis, Emphysema
CountriesUnited States
CollaboratorsCenters for Medicare and Medicaid Services, Hill-Rom
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2004
First PostedSep 2005
Primary CompletionNov 2007
Study CompletionDec 2007
TodayJul 2026
First PostedSep 16, 2005
Enrollment StartMay 1, 2004
Primary CompletionNov 1, 2007
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.8 years ago
Interventions
pneumatic vestdevice
placebo pneumatic vestother