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

This study has been completed.
Sponsor:
Collaborator:
Hill-Rom
Information provided by (Responsible Party):
Jerry A. Krishnan, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181285
First received: September 15, 2005
Last updated: May 9, 2013
Last verified: May 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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 ]

Enrollment: 6
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
Sham Comparator: 1
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: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Johns Hopkins University
Hill-Rom
Investigators
Principal Investigator: Jerry A Krishnan, MD, PhD University of Chicago
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jerry A. Krishnan, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181285     History of Changes
Other Study ID Numbers: 14831A
Study First Received: September 15, 2005
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014