The Role of Patient-Centered Outcomes in the Course of Chronic Obstructive Pulmonary Disease: How Long-Term Studies Contribute to Our Understanding

Abstract

In chronic obstructive pulmonary disease (COPD), the rate of decline in forced expiratory volume in 1 second (FEV 1) and progression to disability and death are accelerated. COPD management goals include preventing or slowing the progressive loss of lung function, relieving symptoms, improving exercise tolerance and the patient’s health status, preventing and treating exacerbations and complications, minimizing side effects of treatment, and reducing mortality. Although lung function is important for diagnosis of COPD and classification of its severity, clinicians and patients are also very interested in symptoms, ability to function, and general well-being (health status). Consequently, increasing attention is being given to these patient-centered outcomes. It is possible to modify patient-centered outcomes; however, it remains to be seen whether doing so can also alter the natural course of the disease and reduce mortality. Two long-term clinical trials—Towards a Revolution in COPD Health (TORCH) and Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT)—will help to answer the question of whether pharmacologic interventions are effective in changing the clinical course of COPD. The TORCH study examines the long-term effects of combination therapy with an inhaled long-acting β-agonist (salmeterol) and a corticosteroid (fluticasone) on reduction of all-cause mortality over 3 years. The 4-year UPLIFT study examines the effects of maintenance treatment with the once-daily anticholinergic bronchodilator tiotropium on the yearly rate of decline in trough FEV 1 and the yearly rate of decline in FEV 1 90 minutes after maximal or near-maximal bronchodilator administration. This article examines the rationale for each of these studies and provides an overview of study methodology as well as preliminary demographic data.