Mar. 6, 2002 Researchers from the University of Chicago have found that the corticosteroid nasal spray fluticasone propionate (Flonase®) is slightly more effective at controlling seasonal allergies than a combination of two popular anti-allergy drugs: loratidine (Claritin®) and montelukast (Singulair®).
The study was presented March 4 at the 58th annual meeting of the American Academy of Allergy, Asthma and Immunology.
"Both approaches worked well with minimal side effects," said Robert Naclerio, M.D., professor of surgery at the University of Chicago and director of the study, "but in our small study the symptom scores were slightly better and the measures of inflammation were significantly better for those taking fluticasone.
"Because of the effect on inflammation, we prefer fluticasone," he added, "but for patients, the choice may come down to cost and whether they would prefer a pill or a spray."
Since one out of five people in the United States suffers from seasonal allergies, such preferences have financial implications. Antihistamines are prescribed three times as often, even though intranasal corticosteroids are less expensive than the non-sedating antihistamines. Combining loratidine with montelukast increases the cost difference.
A daily dose of Claritin, the leading antihistamine, costs $2.92 at the University of Chicago Hospitals pharmacy. Singulair, which works by blocking leukotrienes -- substances that trigger inflammation -- costs $4 per day. Flonase, the leading prescription nasal spray, costs $2.21 per day.
Since loratidine and montelukast are effective alone and act through different mechanisms, the makers of these drugs joined forces to combine them. The only published previous study found the two drugs together were somewhat more effective than either drug used alone. This study compared this combination against the popular nasal spray.
The researchers enrolled 60 patients with ragweed allergies in a randomized, double-blind, double-dummy study that lasted two weeks during the 2000 hay fever season in Chicago. The patients were matched for allergy severity and divided into two groups.
One group (29) received fluticasone once a day, plus placebo pills. The other group (31) received a placebo nasal spray plus loratadine and montelukast once a day.
Two weeks later, the nasal spray group reported a greater reduction of allergy symptoms -- such as sneezing, runny nose and congestion -- than the pill group. On a scale of zero (no symptoms) to 12 (severe symptoms), the fluticasone group had a median score of 4.5, while the loratadine/montelukast group had a score of 6.
On a quality-of-life survey, which looked at the impact of allergies on factors such as sleep, emotions and daily activities, the fluticasone group had significantly fewer allergy-related problems. Overall scores for the fluticasone group fell from 2.8 (on a scale of zero to seven) before the study to 1.4 after two weeks, while the loratadine/montelukast scores fell from 2.6 before the study to 1.7 after two weeks.
In addition, the nasal spray group had better scores for two biomarkers of an allergic reaction. They had fewer eosinophils -- a type of immune cell associated with allergies -- in their nasal passages at two weeks. They also had lower levels of eosinophil cationic protein, another sign of inflammation.
Side effects were minimal. Five of the 29 people on fluticasone and six of 31 on loratadine and montelukast complained of headache.
"Our study supports the addition of the combination of montelukast and loratadine to the clinician's choices for the treatment of seasonal allergic rhinitis," noted the authors. "But it also suggests," added Naclerio, "that fluticasone, which is less expensive, may be a better first choice."
A previous study by the same group found that the nasal spray was more effective than antihistamines when used as needed rather than daily throughout the allergy season.
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