The US FDA has approved the long-acting muscarinic antagonist tiotropium bromide (Spiriva Respimat, Boehringer Ingelheim) for long-term maintenance treatment of asthma in people aged 12 years and older, according to a company statement.
Spiriva Respimat is already approved in the United States for the maintenance treatment of COPD, at a once-daily dose of 5 ?g (delivered in two puffs of 2.5 ?g each).
For asthma maintenance, the FDA approved a once-daily dose of 2.5 ?g (delivered in two puffs of 1.25 ?g each).
Spiriva Respimat is not a treatment for the sudden symptoms of asthma or COPD.
The new indication for asthma maintenance therapy was based on efficacy and safety data from 12 trials involving 5000 adults and adolescents with mild, moderate, and severe symptomatic asthma receiving at least an inhaled corticosteroid.
- Disorders & Diseases
- Public Health
- Products & Treatment
- Department Management