Paul M. Lehrer - US grants

This study will evaluate intensive relaxation therapy as a nonpharmacological treatment of asthma, using results of methacholine challenge testing as the primary measure of asthma. Large vs. small airway involvement in asthma (as assessed by heliox testing) and emotional contributions to asthmatic symptomatology (assessed by questionnaire) will be examined as predictors of response to treatment. Pilot data suggest a response to treatment on the methacholine challenge that is stronger than that found in static spirometry assessment. Also, relaxation therapy appears to be an effective treatment for asthma accompanied by large airway, but not small airway, obstruction. This study will examine these relationships in a controlled study with an adequate n. The relationship between large airway asthma and the psychosomatic contribution to asthma also will be studied. Thirty asthmatic subjects between the ages of 18 and 65 will be assigned to each of three experimental groups, matched on asthma severity and relative large vs. small airway obstruction. The groups will be progressive relaxation, self-relaxation-and-music placebo, and waiting list. Subjects in the relaxation and placebo groups will receive 8 sessions of small group treatment, approximately 1 1/2 hours in length, twice weekly. Pretraining and post-training, subjects will be administered the SCL-90R, and questionnaire measures of the emotional, physical, and respiratory precursors of an asthmatic attack and the degree to which subjects expose themselves to precipitant stressors. At Sessions 1, 4, and 8 (or 3 times for Waiting List Group, spaced approximately every 2 weeks) subjects will be administered an asthma symptom questionnaire as well as pre-session and post-session measures of FEV-1, heliox flow mechanics, and resting surface EMG from the frontalis laryngeal and dominant trapezius areas. A brief daily questionnaire includes measures of drug usage, symptomatology, medical interventions, and exposure to situations that tend to trigger symptoms. Subjects will assess their peak flow twice daily using a hand-held peak flow meter. Expectancies will also be assessed. Follow-up data will be taken for six months following post-treatment testing, and, at the six-month period, methacholine and heliox data again will be taken as well as the various questionnaire measures given at posttest. S's will receive subsidized medical care to maximize motivation and standardization.

respiratory disease /disorder therapy; biofeedback; human therapy evaluation; asthma; arrhythmia; baroreflex; respiratory function; heart rate; patient monitoring device; blood pressure; pulmonary respiration; respiratory airway volume; clinical research; electrocardiography; human subject; spirometry;

DESCRIPTION (provided by applicant): Asthma affects 10% of the US population, with 500 annual deaths. About 50% of asthma patients do not take recommended anti-inflammatory medication, fearing side effects, expense, etc. A nondrug alternative treatment with anti-inflammatory effects could protect these patients from exacerbations. A method that dilates the airways may be helpful as a complementary treatment, and may block progression of exacerbations,once started. The purpose of this study is to evaluate the role of heart rate variability biofeedback (HRV-BF) in asthma therapy by examining its effects on airways reactivity and inflammation, two underlying processes thought to be central characteristics of asthma. It will test the efficacy of HRV-BF as either an alternative or complement to inhaled steroid medication. Our previous research found that it decreased asthma symptoms, improved lung function, and decreased number of exacerbations, with decreased amounts of asthma medication. This study will investigate its role as an alternative or complementary treatment for asthma, vis-`- vis inhaled steroids, by studying its effects as an anti-inflammatory and a bronchodilator agent. In an exploratory analysis, we also will estimate its proportional effect compared with a recommended dose of budesonide. To best observe the effects of HRV-BF on airways biology we will study steroid-naove patients with mild to moderate asthma. The primary outcome measure will be airways reactivity, assessed by a methacholine challenge test. A secondary outcome measure will be exhaled nitric oxide, a measure of airways inflammation. Sixty subjects with mild to moderate asthma will each be assigned to one of two groups, one receiving HRV-BF and one receiving a placebo biofeedback condition (PBO-BF). A third group of 38 subjects will receive HRV-BF and one month of a standard inhaled corticosteroid dose (budesonide 720 mcg/day) to allow us to estimate the proportion of budesonide effects produced by HRV-BF. Subjects will receive 10 sessions of HRV or PBO BF training, preceded by a one-month behavioral run-in, to more accurately assess asthma severity and ability to carry out study procedures. The study will take place in two collaborating sites to insure objectivity, expertise, and meeting recruitment goals. The UMDNJ site conducted the original study and has major biofeedback expertise, while the National Jewish Health site is an internationally respected asthma treatment center, with major clinical trials expertise. We will take additional exploratory outcome measures evaluating the effect of HRV-BF on asthma symptoms, pulmonary function (through spirometry and forced oscillation pneumography), asthma quality of life, and psychological stress.