Safety of tiotropium Respimat (R) in black or African-American patients with symptomatic asthma

Background: Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat (R), as add-on to at least inhaled corticosteroids (ICS), improves lung function and asthma control and reduces asthma exacerbation risk in patients, with a safety profile comparable with placebo. This study aimed to assess the safety of tiotropium Respimat (R), compared with placebo, in black or African-American patients.

Methods: Data were pooled from 12 randomized, placebo-controlled, parallel-group, Phase II or III trials from the global Boehringer Ingelheim program with once-daily tiotropium Respimat (R) (5 mu g or 2.5 mu g). Trial participants had symptomatic persistent asthma with a broad range of severities and were aged 1-75 years. The safety results of black or African-American patients were compared with the overall trial population.

Results: Of the 5165 patients treated with tiotropium or placebo, 3.2% were black or African American. For both doses of tiotropium, the proportion of patients reporting adverse events (AEs) was approximately 10% lower compared with placebo and was generally comparable with the proportion of patients reporting AEs in all groups of the overall population. The number of investigator-assessed drug-related AEs, AEs leading to trial drug discontinuation or serious AEs reported by patients was low and comparable between treatment groups and with the overall population.

Conclusion: Tiotropium Respimat (R) appears to be a generally safe add-on bronchodilator treatment option to ICS with or without other controllers in pediatric and adult black or African-American patients with asthma.