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Tiotropium (trade names Spiriva, Stiolto) was originally FDA-approved after patients with severe chronic obstructive pulmonary disease (COPD) had improved lung function and fewer COPD exacerbations taking Spiriva compared to placebo.
In a recent randomized trial of 841 patients in China, tiotropium showed benefits in milder, early COPD as well.
Patients with COPD GOLD stage 1 or 2 who used tiotropium once daily for two years had a slower decline in the forced expiratory volume in 1 second (FEV1), and also experienced fewer COPD exacerbations on average. Patients taking tiotropium had an annual decline in FEV1 of about 29 mL per year, compared to 51 mL per year for placebo treated patients. The trial was reported in the New England Journal of Medicine.
Patients with early-stage COPD taking tiotropium also had slightly fewer COPD exacerbations than those taking placebo. There were similar rates of adverse events in both treatment groups.
Tiotropium is a long-acting muscarinic antagonist (LAMA) with FDA indications for moderate-to-severe COPD. The new trial opens the door for expansion of tiotropium's FDA indication to include patients with milder COPD.
This trial showed that tiotropium was effective in improving lung function and quality of life and resulted in a lower frequency of acute COPD exacerbations than placebo among patients with GOLD stage 1 or 2 disease.
Because COPD's natural course may occur over decades, the trial's two year duration could not prove that early tiotropium alters the long-term course of COPD. Almost 20% of the Chinese study population had never smoked cigarettes; biofuel and air pollution were considered to be the likely cause of their COPD. This may limit the study's applicability to patients in the U.S.
Read more: Tiotropium in Early-Stage Chronic Obstructive Pulmonary Disease. N Engl J Med 2017; 377:923-935.