The US Food and Drug Administration (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 chronic obstructive pulmonary disease (COPD), at a once-daily dose of 5 μg (delivered in two puffs of 2.5 μg each).
For asthma maintenance, the FDA approved a once-daily dose of 2.5 μg (delivered in two puffs of 1.25 μg 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.
In these trials, the addition of Spiriva Respimat significantly improved lung function and reduced asthma flares compared with placebo, the company said. The most common adverse effects (>2% incidence) were sore throat, sinus infections, bronchitis, and headache in adults.
"In my clinical experience, some patients with uncontrolled asthma, despite treatment, continue to experience symptoms, which can include coughing, wheezing, waking at night or shortness of breath," William Busse, MD, Division of Allergy, Pulmonary and Critical Care, University of Wisconsin School of Medicine and Public Health, Madison, said in a company news release.
"For patients who continue to experience these symptoms, Spiriva Respimat is a once-daily maintenance treatment that has been shown to provide additional bronchodilation to help patients breathe better and reduce asthma attacks," he added.
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Cite this: Tiotropium (Spiriva Respimat) Gets Asthma Indication in US - Medscape - Sep 16, 2015.