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

NCT00181207 | Completed Phase 4 Results

• 2 other identifiers: NA_00020218-P-92858/3-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Chronic Bronchitis; Emphysema

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria.

  count of exacerbations per group per 12 weeks. An exacerbation was defined based on three major symptoms: increasing dyspnea, increasing sputum purulence and increasing sputum volume. Exacerbations were counted if there were at least 2 of these 3 symptoms.

  12 weeks

Secondary Outcomes (1)

• Quality of Life

  Change from baseline to 12 weeks

Study Arms (2)

Active

EXPERIMENTAL

Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks

Device: pneumatic vest

Sham

PLACEBO COMPARATOR

Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating.

Other: placebo pneumatic vest

Interventions

pneumatic vest DEVICE

Active

placebo pneumatic vest OTHER

Sham

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician Diagnosis of COPD,chronic bronchitis and/or emphysema
• Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) \< or = 70%
• FEV1 \< or = 65%
• Current or former smoker \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Centers for Medicare and Medicaid Services: collaborator
• Hill-Rom: collaborator

Study Sites (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Results Point of Contact

• Title: Gregory Diette
• Organization: Johns Hopkins University

gdiette@jhmi.edu

410-955-3497

Study Officials

• Gregory B Diette, M.D.,M.H.S

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-02

Locations

US (1)