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

Condition(s) targeted: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Undifferentiated Asthma/COPD

Intervention: Prednisone (Drug); Albuterol (Drug); Advair (Drug); High Frequency Chest Wall Oscillator (Device)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Jerry A Krishnan, MD, PhD, Principal Investigator, Affiliation: University of Chicago

Overall contact:
Jerry A Krishnan, MD PhD, Phone: (773) 702-6790, Email: jkrishna@medicine.bsd.uchicago.edu

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.

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.

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome:

Post-bronchodilator spirometry will be performed to evaluate lung function (FEV1)

Length of hospital stay is defined as day of admission minus day of hospital discharge.

Symptom control/health-related quality of life will be assessed using interviewer-administered surveys

Re-exacerbation within 30 days of hospital discharge

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.

Minimum age: 18 Years. Gender(s): Both.

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

Jerry A Krishnan, MD PhD, Phone: (773) 702-6790, Email: jkrishna@medicine.bsd.uchicago.edu

The University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Jerry A Krishnan, MD, PhD, Phone: 773-702-6790, Email: jkrishna@medicine.bsd.uchicago.edu
Sonya Rawls, RN, MSN, Phone: (773) 702-5886, Email: srawls@medicine.bsd.uchicago.edu
Jerry A Krishnan, MD, PhD, Principal Investigator

Starting date: October 2003
Last updated: October 17, 2007