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

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).

Study Overview

• Status: Completed
• Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Undifferentiated Asthma/COPD
• Intervention / Treatment: Device: High Frequency Chest Wall Oscillator

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Mercy Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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	Device: High Frequency Chest Wall Oscillator; High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Adherence to High Frequency Chest Wall Oscillation	Patient adherence to therapy after four treatments.	After four treatments of 15 minutes each
Number of Participants Who Considered the Pneumatic Vest Convenient to Use	The study vest was convenient to use.	After four treatments of 15 minutes each

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Hill-Rom
• Investigators: Principal Investigator: Jerry A Krishnan, MD, PhD, University of Illinois at Chicago

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: September 15, 2005
• First Submitted That Met QC Criteria: September 15, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: 14831A