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

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ClinicalTrials.gov Identifier: NCT00181285
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : August 7, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Hill-Rom
Information provided by (Responsible Party):
University of Chicago

Study Description
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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).

Condition or disease Intervention/treatment Phase
Asthma Chronic Obstructive Pulmonary Disease (COPD) Undifferentiated Asthma/COPD Device: High Frequency Chest Wall Oscillator Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)
Study Start Date : October 2003
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Sham high frequency chest wall oscillation
Sham high frequency chest wall oscillation
 Device: High Frequency Chest Wall Oscillator
High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax
Active Comparator: Active high frequency chest wall oscillation
Active high frequency chest wall oscillation
 Device: High Frequency Chest Wall Oscillator
High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax


Outcome Measures
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Primary Outcome Measures :
  1. Patient Adherence to High Frequency Chest Wall Oscillation [ Time Frame: After four treatments of 15 minutes each ]
    Patient adherence to therapy after four treatments.

  2. Number of Participants Who Considered the Pneumatic Vest Convenient to Use [ Time Frame: After four treatments of 15 minutes each ]
    The study vest was convenient to use.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181285


Locations
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United States, Illinois
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
University of Chicago
Hill-Rom
Investigators
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Principal Investigator: Jerry A Krishnan, MD, PhD University of Illinois at Chicago
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00181285    
Other Study ID Numbers: 14831A
First Posted: September 16, 2005    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 8, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Asthma
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
 Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases