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Sponsors and Collaborators: |
University of Chicago Hill-Rom |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00181285 |
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 |
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Asthma Chronic Obstructive Pulmonary Disease (COPD) Undifferentiated Asthma/COPD |
Device: High Frequency Chest Wall Oscillator |
Phase II |
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) |
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 |
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1: Sham Comparator
Sham high frequency chest wall oscillation.
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Device: High Frequency Chest Wall Oscillator
High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax
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2: Active Comparator
High frequency chest wall oscillation
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Device: High Frequency Chest Wall Oscillator
High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Mercy Hospital and Medical Center | |
Chicago, Illinois, United States, 60616 |
Principal Investigator: | Jerry A Krishnan, MD, PhD | University of Chicago |
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 |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity Pulmonary Disease, Chronic Obstructive |
Immune System Diseases Bronchial Diseases |