From the American College of Allergy, Asthma & Immunology
PHILADELPHIA—The investigational antihistamine olopatadine nasal spray (Patanase; Alcon), currently under FDA review, appears to be safe and well-tolerated in patients with seasonal allergic rhinitis, new data presented at the American College of Allergy, Asthma & Immunology annual meeting show. And data from another study show that a combination of the nasal antihistamine azelastine (Astelin) and a steroid is better than monotherapy for this patient population.
“There are many unmet needs for these patients, so it is important to develop newer agents that may improve upon what is already out there,” said Paul Ratner, MD, medical director of Sylvana Research, San Antonio, Tex, and an allergist in private practice.
If approved, olopatadine “would be the second medication in this class, which ultimately may help drop the cost of the existing medication. Azelastine is the only nasal antihistamine on the market now,” said Dr Ratner.
In this randomized, double-blind, placebo-controlled, multicenter, parallel-group study, patients were randomized to olopatadine 0.6%, azelastine 0.1%, or placebo for 14 days. Safety results were based on 544 patients who completed the treatment phase.
Localized side effects were mild and less common in patients receiving olopatadine than in those randomized to azelastine. Taste perversion was 12.2% with olopatadine compared with 19.7% for azelastine and 1.7% for placebo ( = .05). Mean intensity of taste perversion was lower with olopatadine compared with azelastine ( <.001). With the exception of taste perversion, all other adverse events were similar in the 2 treat-ment groups.
Combination Therapy Superior to Monotherapy
Dr Ratner presented a second study that showed that a combination of the antihistamine nasal spray azelastine and the corticosteroid nasal spray ­fluticasone dipropionate (Flonase) was more effective than either agent alone. This 3-arm trial included 151 patients (aged 12-73 years; 63% women) with moderate-to-severe ­allergies to mountain cedar who were randomized to azelastine (2 sprays per nostril twice daily), fluticasone (2 sprays per nostril once daily), or both agents together at the same doses for a 2-week period.
A 40% improvement in total nasal symptom score was reported in those receiving the combination compared with each agent alone. This unexpected finding contradicts previous studies showing no appreciable benefit when combining these 2 agents.
“This is the first time that anyone has shown that an antihistamine has an added effect when used with a nasal steroid.” Dr Ratner told IMWR. “These were fairly sick patients, so these findings are rather significant.” He added that this combination may be an additional treatment option for patients who do not respond optimally to nasal steroids alone.