Spiriva Respimat Gets Expanded Approval for Pediatric Asthma Maintenance
The Food and Drug Administration (FDA) has approved Spiriva Respimat (tiotropium bromide inhalation spray; Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in patients as young as 6 years old.
This approval was based on efficacy and safety data from the Phase 2 and Phase 3 UniTinA-asthma clinical development program which included 804 children (aged 6–11 years). The safety and efficacy of Spiriva Respimat have not been established in pediatric patients less than 6 years of age.
Tiotropium is a long-acting, antimuscarinic agent that inhibits the M3-receptors at the smooth muscle leading to bronchodilation. The bronchodilation following inhalation of tiotropium is predominantly a site-specific effect. The Respimat formulation uses mechanical energy to deliver the drug as a slow-moving mist that is independent of the patient's inspiratory effort.
Previously, Spiriva Respimat was approved for the maintenance treatment of asthma in patients 12 years of age and older, in addition to the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. It is not intended for the relief of acute bronchospasm.
Spiriva Respimat is available in two dosage strengths. To deliver the recommended dosage for asthma, the 1.25mcg/actuation strength should be used. To deliver the recommended dosage for COPD, the 2.5mcg/actuation strength should be used. Each inhaler delivers 60 metered actuations.
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