Methods: The prevalence of asthma in adults in the United States is approximately 7%, and 9% of asthma patients will require hospitalization each year. Many patients do not seek care, as they do not recognize overuse of beta-agonists as a risk factor for poorly controlled asthma. However, pharmacists are able to identify these patients through refill information on reliever medication prescriptions and potentially initiate community-management opportunities for these patients. Design: The study is a randomized, controlled trial. Patients are randomized to intervention or usual care. Study population: Patients are high-risk asthma patients (defined as having an ER visit or hospitalization in the previous year, or using >2 canisters of short-acting beta-agonist in the previous 6 months). They are identified through community pharmacies. Objectives: The primary objective is to determine the effect of an education and referral intervention program initiated by community pharmacists, working with high-risk asthma patients, family physicians and respiratory therapists, on asthma control, as measured by the Asthma Control Questionnaire (ACQ). Secondary objectives include determining the effect of this program on ER visits/hospitalizations, inhaled corticosteroid use, courses of oral steroids and FEV1. Intervention: The intervention includes patient education, assessment and optimization of drug therapy, and physician referral as needed. Patients are referred to a respiratory therapist within 1 week of randomization for measurement of FEV1 and reinforcement of education. Patients assigned to usual care receive written asthma information, referral to a respiratory therapist and usual pharmacy and physician care. Unique aspects: The design of the Better Respiratory Education and Asthma Treatment in Hinton and Edson (BREATHE) study is unique, given the multidisciplinary involvement, rural and community based, pharmacist initiated and targets specifically high risk patients. We believe that this study will show that management of asthma patients, involving the major role-players in their asthma care, will improve their asthma control. (C) 2004 Elsevier Inc. All rights reserved.