search
Back to results

Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease (COPD), Undifferentiated Asthma/COPD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Frequency Chest Wall Oscillator
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 years and older Admission to the inpatient medical service Physician-diagnosed asthma or asthma/COPD or COPD exacerbation. Evidence of airflow obstruction on spirometry Exclusion Criteria: More than 24 hours since admission to the inpatient medical service Admission to an intensive care unit Hospital discharge planned within the next 24 hours Other chronic respiratory disease (e.g., sarcoidosis, idiopathic pulmonary fibrosis) Chest wall abnormalities (e.g., severe kyphoscoliosis) that precludes using the vest Chest wall or abdominal trauma/surgery in the past 6 weeks that precludes using the vest Physician declines to provide consent Patient unable (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent Previous participant in this study Corticosteroid therapy (prednisone >0 mg/d equivalent) for >1 week prior to admission

Sites / Locations

  • Mercy Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham high frequency chest wall oscillation

Active high frequency chest wall oscillation

Arm Description

Sham high frequency chest wall oscillation

Active high frequency chest wall oscillation

Outcomes

Primary Outcome Measures

Patient Adherence to High Frequency Chest Wall Oscillation
Patient adherence to therapy after four treatments.
Number of Participants Who Considered the Pneumatic Vest Convenient to Use
The study vest was convenient to use.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2005
Last Updated
August 6, 2018
Sponsor
University of Chicago
Collaborators
Hill-Rom
search

1. Study Identification

Unique Protocol Identification Number
NCT00181285
Brief Title
Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)
Official Title
Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Hill-Rom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study was to evaluate the use of high frequency chest wall oscillation (HFCWO) early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD).
Detailed Description
Acute asthma and chronic obstructive pulmonary disease (COPD) are exceedingly common, which together account for nearly 1 million hospitalizations each year in the United States alone. Beta agonists, anticholinergics, and corticosteroids delivered in aerosolized forms (via respiratory inhalers or nebulization) are recommended in the treatment of acute asthma and COPD. These medications rely on deposition into distal airspaces to suppress airway inflammation or promote bronchodilation. Unfortunately, excessive mucous production and impaired airway mucociliary clearance can lead to airway plugging, and thereby reduce the deposition of and response to aerosolized medications. These considerations highlight the need for therapies that clear airways of mucus in the acute management of asthma and COPD. High frequency chest wall oscillation (HFCWO) creates high velocity, low amplitude oscillatory airflows when applied through a pneumatic vest worn over the thorax, and is used for airway mucus clearance in patients with cystic fibrosis, bronchiectasis, and neuromuscular disorders. This was a randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease (COPD), Undifferentiated Asthma/COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham high frequency chest wall oscillation
Arm Type
Sham Comparator
Arm Description
Sham high frequency chest wall oscillation
Arm Title
Active high frequency chest wall oscillation
Arm Type
Active Comparator
Arm Description
Active high frequency chest wall oscillation
Intervention Type
Device
Intervention Name(s)
High Frequency Chest Wall Oscillator
Intervention Description
High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax
Primary Outcome Measure Information:
Title
Patient Adherence to High Frequency Chest Wall Oscillation
Description
Patient adherence to therapy after four treatments.
Time Frame
After four treatments of 15 minutes each
Title
Number of Participants Who Considered the Pneumatic Vest Convenient to Use
Description
The study vest was convenient to use.
Time Frame
After four treatments of 15 minutes each

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and older Admission to the inpatient medical service Physician-diagnosed asthma or asthma/COPD or COPD exacerbation. Evidence of airflow obstruction on spirometry Exclusion Criteria: More than 24 hours since admission to the inpatient medical service Admission to an intensive care unit Hospital discharge planned within the next 24 hours Other chronic respiratory disease (e.g., sarcoidosis, idiopathic pulmonary fibrosis) Chest wall abnormalities (e.g., severe kyphoscoliosis) that precludes using the vest Chest wall or abdominal trauma/surgery in the past 6 weeks that precludes using the vest Physician declines to provide consent Patient unable (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent Previous participant in this study Corticosteroid therapy (prednisone >0 mg/d equivalent) for >1 week prior to admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry A Krishnan, MD, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21906390
Citation
Mahajan AK, Diette GB, Hatipoglu U, Bilderback A, Ridge A, Harris VW, Dalapathi V, Badlani S, Lewis S, Charbeneau JT, Naureckas ET, Krishnan JA. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial. Respir Res. 2011 Sep 10;12(1):120. doi: 10.1186/1465-9921-12-120.
Results Reference
derived

Learn more about this trial

Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)

We'll reach out to this number within 24 hrs