8-10) Other possible current choices for long-term controller medical therapy include leukotriene-receptor antagonists, such as montelukast or zafirlukast, long-acting beta agonists
, such as formoterol or salmeterol, or the phosphodiesterase inhibitor, theophylline.
Although several types of drugs are available to treat asthma, long-acting beta agonists
(LABAs) are among the most commonly used and work well for most people.
Higher doses of corticosteroids do not improve symptoms for all patients and can have significant side effects, while long-acting beta agonists
have come under scrutiny for their risk of worsening asthma symptoms that could result in hospitalization and, rarely, death.
In the study, patients with moderate to severe asthma who were inadequately controlled on the combination of inhaled corticosteroids (ICS) and long-acting beta agonists
(LABA) were assigned to receive one of three doses (1 mg, 3 mg or 10 mg) of Aerovant or placebo by inhalation twice daily for 12 weeks.
These proposed labeling changes would reserve the most effective asthma treatment -- the combination of inhaled corticosteroids and long-acting beta agonists
-- until after a patient has failed on other treatment options and therefore may be at risk for severe outcomes, such as exacerbations and potentially death.
The randomized, double-blind, placebo-controlled study will be conducted in the United States in 120 symptomatic asthma patients who are not being treated with controller medications including inhaled steroids, leukotriene modifiers or long-acting beta agonists
The FDA based its approval decision on a randomized, double-blind, controlled trial of 297 patients with severe, persistent asthma who experienced symptoms despite treatment with inhaled corticosteroids and long-acting beta agonists
In terms of asthma management, beta-2 agonists are classified as either short-acting beta agonists (SABAs) or long-acting beta agonists
Asthma "controllers" are claims for inhaled steroids, cromolyn, leukoriene, and long-acting beta agonists