SAN ANTONIO — Once-daily tiotropium bromide as an add-on to inhaled corticosteroid therapy demonstrated comparable safety and tolerability as placebo among adolescents with moderate or severe symptomatic asthma, according to study results presented at the 2015 American College of Allergy, Asthma and Immunology Annual Scientific Meeting.
“Adding [tiotropium bromide] on to therapy in the teenagers who were not completely controlled caused a benefit in pulmonary function and decrease in [asthma] exacerbations,” Lyndon E. Mansfield, MD, an allergist at Allergy Partners of El Paso, told Healio.com/Allergy.
Mansfield and colleagues analyzed data from two randomized, double blind phase 3 trials composed of adolescents with moderate or severe symptomatic asthma. Researchers assessed the safety and tolerability of once-daily tiotropium bromide (Spiriva Respimat, Boehringer Ingelheim) in adolescent patients aged 12 to 17 years.
The one trial was a 48-week study of once-daily tiotropium bromide 5 μg, once-daily tiotropium bromide 2.5 μg or placebo as an add-on therapy to inhaled corticosteroid (12-14 years: 200-800 μg budesonide or equivalent; 15-17 years: 400-800 μg)
The second trial consisted of a 12-week study of once-daily tiotropium bromide 5 μg, once-daily tiotropium bromide 2.5 μg or placebo as add-on to inhaled corticosteroid (12-14 years: >400 μg budesonide or equivalent; 15-17 years: 800-1600 μg) plus at least one controller, or stable ICS (12-14 years: 200-800 μg budesonide or equivalent; 15-17 years: 400-800 μg) plus at least two controllers.
The total analysis included 789 patients.
Forty-eight percent of adolescents (n = 252) who received 2.5 μg of tiotropium bromide experienced an adverse event, whereas 48.1% of patients who received 5 μg of tiotropium bromide (n = 264) and 47.6% of patients who received placebo (n = 273) experienced an adverse event.
The most common adverse events included asthma exacerbations. These occurred among 14.4% of patients who received the 5 μg dose, 16.3% in patients who received the 2.5 μg dose and 16.8% of patients who received placebo.
The FDA recently approved Spiriva Respimat for asthma in adults and adolescents.
“When you have an adolescent that is out of control, you have another approved means of controlling their asthma,” Mansfield told Healio.com/Allergy. “It [also] means you may not have to raise the steroid dose.” – by Ryan McDonald
Mansfield L, et al. Poster 56. Presented at: American College of Allergy, Asthma and Immunology Annual Scientific Meeting; Nov. 5-9; San Antonio.
Disclosure: Mansfield served as a paid investigator for this study.