Gustavo J Rodrigo1, José A Castro-Rodríguez2. 1. Department of Emergency, Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay. Electronic address: gustavo.javier.rodrigo@gmail.com. 2. Departments of Pediatrics and Family Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.
Abstract
BACKGROUND: The role of tiotropium for the treatment of adolescents with asthma has not yet been clearly defined. OBJECTIVE: To assess the efficacy and safety of inhaled tiotropium in adolescents with moderate to severe symptomatic asthma. METHODS: Randomized, placebo-controlled trials were included in this systematic review. Primary outcomes were peak and trough forced expiratory volume in 1 second (FEV1). RESULTS: Three studies (approximately 1,000 patients) were included. Tiotropium was associated with significant improvements in FEV1 peak (mean change from baseline) by 120 mL (P < .001) and trough by 100 mL (P < .001) compared with placebo. Tiotropium significantly reduced the percentage of patients who experienced an Asthma Control Questionnaire 7 worsening episode defined as a change from trial baseline of 0.5 points or more compared with placebo (2.1% vs 4.8%, number needed to treat = 38) and also was associated with a significantly decreased in the number of patients with at least one exacerbation compared with placebo (17.6 vs 23.8%, number needed to treat = 16). Finally, no significant differences were found in rescue medication use, withdrawals, withdrawals due to adverse events (AEs), AEs (27.3% vs 27.1%), and serious AEs (6.5% vs 7.1%). Tiotropium in doses of 2.5 μg once daily or 5.0 μg once daily resulted in equivalent effects. CONCLUSIONS: Tiotropium was well tolerated and efficacious as an addition to maintenance treatment with an inhaled corticosteroid or an inhaled corticosteroid plus a long-acting β-agonist in adolescents with moderate to severe asthma. Available data do not suggest an advantage of the 5-μg once-daily dose (used in adults) compared with the 2.5-μg once-daily dose of tiotropium.
BACKGROUND: The role of tiotropium for the treatment of adolescents with asthma has not yet been clearly defined. OBJECTIVE: To assess the efficacy and safety of inhaled tiotropium in adolescents with moderate to severe symptomatic asthma. METHODS: Randomized, placebo-controlled trials were included in this systematic review. Primary outcomes were peak and trough forced expiratory volume in 1 second (FEV1). RESULTS: Three studies (approximately 1,000 patients) were included. Tiotropium was associated with significant improvements in FEV1 peak (mean change from baseline) by 120 mL (P < .001) and trough by 100 mL (P < .001) compared with placebo. Tiotropium significantly reduced the percentage of patients who experienced an Asthma Control Questionnaire 7 worsening episode defined as a change from trial baseline of 0.5 points or more compared with placebo (2.1% vs 4.8%, number needed to treat = 38) and also was associated with a significantly decreased in the number of patients with at least one exacerbation compared with placebo (17.6 vs 23.8%, number needed to treat = 16). Finally, no significant differences were found in rescue medication use, withdrawals, withdrawals due to adverse events (AEs), AEs (27.3% vs 27.1%), and serious AEs (6.5% vs 7.1%). Tiotropium in doses of 2.5 μg once daily or 5.0 μg once daily resulted in equivalent effects. CONCLUSIONS:Tiotropium was well tolerated and efficacious as an addition to maintenance treatment with an inhaled corticosteroid or an inhaled corticosteroid plus a long-acting β-agonist in adolescents with moderate to severe asthma. Available data do not suggest an advantage of the 5-μg once-daily dose (used in adults) compared with the 2.5-μg once-daily dose of tiotropium.