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Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)
This study has been completed.
Sponsors and Collaborators: University of Chicago
Hill-Rom
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00181285
  Purpose

The purpose of this study is to determine whether inpatient use of a high frequency chest wall oscillator is an effective therapy for patients hospitalized with asthma exacerbations or chronic obstructive pulmonary disease (COPD) exacerbations.

The investigators hypothesize that inpatient use of HFCWO will promote clearance of airway secretions, leading to more rapid resolution of severe asthma and COPD exacerbations and lower rates of re-exacerbations after hospital discharge.


Condition Intervention Phase
Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Undifferentiated Asthma/COPD
Device: High Frequency Chest Wall Oscillator
Phase II

MedlinePlus related topics: Asthma COPD (Chronic Obstructive Pulmonary Disease)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • To evaluate patient acceptability and collect preliminary data about the effectiveness of High Frequency Chest Wall Oscillation (HFCWO) in adults hospitalized for asthma and/or COPD exacerbations [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay is defined as day of admission minus day of hospital discharge. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Symptom control/health-related quality of life will be assessed using interviewer-administered surveys [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Re-exacerbation within 30 days of hospital discharge [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Post-bronchodilator spirometry will be performed to evaluate lung function (FEV1) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: October 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: 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
2: Active Comparator
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

Detailed Description:

Asthma and Chronic Obstructive Pulmonary Disease (COPD) are common chronic pulmonary disorders with periodic exacerbations characterized by increased airway obstruction, mucous hypersecretion, and respiratory symptoms such as dyspnea, cough, and wheeze. Despite major advances in the treatment of these disorders, severe asthma and COPD exacerbations are common and each result in about 500,000 hospitalizations per year in the United States. Moreover, re-exacerbations are common in this population, occurring in about 25% within 1 month and 50% within 12 months of hospital discharge. Inhaled medications, which rely on deposition into distal airspaces to suppress airway inflammation and promote bronchodilation, are used for both the treatment and prevention of asthma and COPD exacerbations. However, excessive mucous production and impaired airway mucociliary clearance lead to airway plugging, reducing the deposition of and response to inhaled medications. These considerations highlight the need for therapies that clear airways of mucus in patients with asthma and COPD. High frequency chest wall oscillation (HFCWO) may be a novel strategy for mechanical airway clearance to improve outcomes in patients with asthma/COPD exacerbations. The feasibility and efficacy of daily HFCWO during severe asthma and COPD exacerbations, however, has not been adequately studied. We hypothesize that inpatient use of HFCWO will promote clearance of airway secretions, leading to more rapid resolution of severe asthma and COPD exacerbations and lower rates of re-exacerbations after hospital discharge. The objectives of this proposal are to conduct a 3-year feasibility study in adults hospitalized for asthma/COPD exacerbation to 1) assess patient acceptability of HFCWO during severe asthma exacerbations, and 2) collect preliminary data about the clinical efficacy of HFCWO when added to conventional medical therapy. These data will serve as the basis for a large, multi-center clinical trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181285

Locations
United States, Illinois
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
University of Chicago
Hill-Rom
Investigators
Principal Investigator: Jerry A Krishnan, MD, PhD University of Chicago
  More Information

Responsible Party: University of Chicago ( Jerry Krishnan, MD, PhD )
Study ID Numbers: 14831A
Study First Received: September 15, 2005
Last Updated: December 22, 2008
ClinicalTrials.gov Identifier: NCT00181285  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009