A review of the efficacy and safety of once-daily tiotropium Respimat 2.5 micrograms in adults and adolescents with asthma.

BACKGROUND: Despite current guidelines, many patients with asthma remain symptomatic, particularly those intolerant of,unresponsive to, or uncontrolled by long-acting beta 2-agonists (LABAs). Tiotropium bromide, delivered through the Respimatsoft-mist inhaler in 2 puffs of 1.25 micrograms each, is approved for the long-term, maintenance treatment of asthma in patients aged greater than or equal to 6 years.

OBJECTIVE: An overview of the use of once-daily tiotropium Respimat 2.5 micrograms in adults and adolescents with varyingdegrees of asthma severity. The role of the parasympathetic nervous system in the pathophysiology of asthma, the developmentof tiotropium for respiratory disease, and the value of the Respimat inhaler are also discussed.

METHODS: A literature search of all phase II and phase III trials of once-daily tiotropium Respimat 2.5 micrograms.

RESULTS: Once-daily tiotropium Respimat 2.5 micrograms was studied in five phase III studies: three studies in adults andtwo in adolescents aged 12-17 years. Tiotropium Respimat 2.5 micrograms demonstrated efficacy in adults and adolescentswith mild, moderate, or severe asthma, showing significant improvements in lung function and asthma control in patients with uncontrolled asthma despite inhaled corticosteroids (ICS) or ICS plus LABA use. The adverse event profile of tiotropium was very acceptable, with safety similar to placebo.

CONCLUSION: Once-daily tiotropium Respimat 2.5 micrograms has positive attributes that include efficacy, a safety profilesimilar to placebo, once-daily dosing, administration by inhalation, and delivery in the easy-to-use and consistent-dosing Respimat device. However, more data are needed on the effects of tiotropium on clinical outcomes, patients' day-to-day lives, and real-world effectiveness.