Phase 4 N=50 Randomized Triple-blind Prevention

Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

COPD · Chronic Bronchitis · Emphysema

Bottom Line

View on ClinicalTrials.gov: NCT00181207 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria. — 5.5; 4 exacerbations per 12 weeks

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: pneumatic vest (Device); placebo pneumatic vest (Other)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria.	5.5; 4	—
SECONDARY Quality of Life	5; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Physician Diagnosis of COPD, chronic bronchitis and/or emphysema
Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) or = 20 pack years
History of 1 or more COPD exacerbations in past 6 months necessitation hospitalization, Emergency Department (ED) visit, antibiotic or steroid prescription

Exclusion Criteria

Other lung diseases
Co-morbid illnesses such as cancer, liver disease, cardiomyopathy
Recent chest wall or abdominal trauma or surgery that would preclude using the vest

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00181207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.