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Mometasone Furoate Useful For Children With Allergic Rhinitis: Presented at EAACI
By Jill Stein
PARIS, FRANCE -- June 11, 2003 -- Children with allergic rhinitis who are treated with once a day mometasone furoate nasal suspension (MFNS) respond well to the drug with no toxic effects.
In a study of 56 children aged 2 to 5 years old who had allergic rhinitis and a positive skin test to pollen or other allergens, researchers observed no effects on the hypothalamic-pituitary-adrenal (HPA) axis and.
These results were reported here on June 8th at the 22nd Congress of the European Academy of Allergology and Clinical Immunology.
Jerry M. Herron, MD, Arkansas Research Medical Testing Center, in Little Rock, Arkansas, led a team of researchers in evaluating the systemic safety of MFNS 100 mcg once each morning at a dose of 50 mcg per spray per nostril for 42 consecutive days, compared with placebo, by measuring HPA axis function.
The study excluded children who had used oral corticosteroids, orally inhaled corticosteroids, or intranasal corticosteroids within the prior 6 months, or intramuscular corticosteroids within the prior year.
Treatments were administered at the study site under the supervision of a blinded third-party administrator to assure compliance. Fifty-two patients completed all 42 days of treatment.
No significant differences were observed between MFNS and placebo treatment in measurements of serum cortisol (measured as the area under the concentration versus time curve [AUC] 0-24) or urinary-free cortisol (corrected for creatinine) at baseline and on day 42. Only one of the plasma samples had a detectable level of mometasone furoate.
Follow-up physical examinations and vital signs for all patients were within normal ranges. No patient showed any clinically relevant changes in electrocardiogram or laboratory tests, and no patient discontinued treatment due to adverse events.
The most common adverse events were mild to moderate headache and rhinorrhoea, which were reported in both the treatment and placebo groups.
[Study title: Systemic Safety Of Once-Daily Treatment With Mometasone Furoate Nasal Spray (MFNS) 100 mcg In Patients Ages 2 to 5 Years Old With Allergic Rhinitis (AR). Abstract 586]
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