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Combination nasal spray well-tolerated among children with allergic rhinitis
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Safety and efficacy of azelastine hydrochloride with fluticasone propionate in a single nasal spray was comparable to fluticasone propionate alone, according to data presented at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting.
William E. Berger, MD, of the University of California, Irvine, Calif., and colleagues randomly assigned children aged 4 to 12 years with allergic rhinitis 3:1 to receive azelastine hydrochloride with fluticasone propionate (n=304) or fluticasone propionate (Dymista, Meda Pharmaceuticals) alone (n=101). Treatments were administered as one spray per nostril twice daily. This open-label, 3-month study was conducted at 42 sites in the United States.
William E. Berger
Results of nasal examinations among both treatment groups improved. Nasal mucosal ulceration or septal perforation did not occur in either treatment group.
Regarding adverse events, epistaxis occurred in 10% of children who received azelastine hydrochloride with fluticasone propionate and 9% of children who received fluticasone propionate alone; headache occurred in 7% vs. 3%; cough occurred in 4% vs. 3%; and pyrexia occurred in 3% vs. 2%.
“Azelastine hydrochloride/fluticasone propionate and fluticasone propionate were well-tolerated during this 3-month study when administered as one spray per nostril twice daily in pediatric subjects aged 4 to 12 years with allergic rhinitis,” the researchers wrote.
For more information:
Berger W. Abstract P301. Presented at: American College of Asthma, Allergy and Immunology Annual Scientific Meeting; Nov. 6-10, 2014; Atlanta.
Disclosure: Infectious Diseases in Children was unable to determine financial disclosures at the time of publication.