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

Not Applicable

Completed

Conditions: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Undifferentiated Asthma/COPD

Interventions: Device: High Frequency Chest Wall Oscillator

Registration Number: NCT00181285

Lead Sponsor: University of Chicago

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 52

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham high frequency chest wall oscillation	High Frequency Chest Wall Oscillator	Sham high frequency chest wall oscillation
Active high frequency chest wall oscillation	High Frequency Chest Wall Oscillator	Active high frequency chest wall oscillation

Primary Outcome Measures

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

Secondary Outcome Measures