Tiotropium in COPD patients not previously receiving maintenance respiratory medications.

INTRODUCTION: Use of maintenance bronchodilator therapy is currently recommended in symptomatic patients with Chronic obstructive pulmonary disease (COPD) and in those with Stage II or greater COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD). Because no prospective data describe when rescue therapy alone is insufficient or the optimal time to start maintenance therapy, it is unclear whether maintenance therapy has benefits in milder disease. To explore potential benefits we asked: Does once-daily tiotropium improve lung function, health status, and/or symptoms in "undertreated" COPD patients (i.e., those who are not receiving maintenance bronchodilator therapy) or patients considered by their health care providers as having milder disease?

METHODS: A post-hoc analysis of data from COPD patients participating in two, 1-year, placebo-controlled trials with tiotropium was performed. Patients were defined as "undertreated" if they received no respiratory medication or only as-needed short-acting beta-agonists prior to enrollment. Measures included serial spirometry, Transition Dyspnea Index (TDI), and St. George's Respiratory Questionnaire (SGRQ).

RESULTS: Of 921 patients enrolled, 218 (23.7%) were "undertreated": 130 received tiotropium; 88 received placebo. Demographics for the two treatment groups were comparable. Tiotropium-treated patients had significantly improved forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) compared with patients using placebo on all study days. Additionally, TDI and SGRQ scores significantly improved with tiotropium compared with placebo.

CONCLUSIONS: Once-daily tiotropium provides significant improvement in lung function, health status, and dyspnea when used as maintenance therapy in undertreated COPD patients who were not previously receiving maintenance bronchodilator therapy.