Onset of symptomatic effect of mometasone furoate nasal spray in the treatment of nasal polyposis

• Published in: Journal of allergy and clinical immunology 2008-04, Vol.121 (4), p.928-932
• Main Authors: Small, Catherine Butkus, MD, Stryszak, Paul, PhD, Danzig, Melvyn, PhD, Damiano, Angela, MD
• Format: Article
• Language: English
• Subjects: Administration, Intranasal; Adolescent; Adult; Aged; Allergies; Allergy and Immunology; Anti-Allergic Agents - administration & dosage; Anti-Allergic Agents - therapeutic use; Asthma - complications; Asthma - drug therapy; Biological and medical sciences; clinical trial; Demographics; Double-Blind Method; Drug therapy; efficacy onset; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Humans; Immunopathology; Inspiratory Capacity - drug effects; intranasal corticosteroids; Male; Medical sciences; Middle Aged; Mometasone Furoate; Nasal Decongestants - administration & dosage; Nasal Decongestants - therapeutic use; Nasal polyposis; Nasal Polyps - diagnosis; Nasal Polyps - drug therapy; Nasal Polyps - etiology; Nose; Placebo effect; Pregnadienediols - administration & dosage; Pregnadienediols - therapeutic use; Rhinitis, Allergic, Perennial - complications; Rhinitis, Allergic, Perennial - drug therapy; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Smell - drug effects; Studies
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2007.11.018

Background The efficacy of the intranasal corticosteroid mometasone furoate nasal spray (MFNS) for treatment of nasal polyposis was demonstrated in 2 large clinical trials. Objective To evaluate the onset of MFNS symptomatic effect, data from the 2 trials were pooled and analyzed to determine the first day subjects experienced significant symptom relief. Methods Subjects with nasal polyposis randomized to MFNS 200 μg twice daily or placebo scored symptoms on a 3-point scale (0 = none; 3 = severe) and measured peak nasal inspiratory flow immediately before the morning dose. Onset of symptomatic effect was defined as the first day a statistically significant ( P < .05) lasting response was observed for MFNS compared with placebo. Results A total of 447 subjects with bilateral nasal polyps and clinically significant nasal congestion/obstruction were analyzed. Compared with placebo, MFNS 200 μg twice daily demonstrated statistically significant ( P < .05) relief of anterior rhinorrhea by day 2 (–10.9% vs +5.7%), nasal congestion by day 3 (–15.1% vs –7.6%), postnasal drip by day 5 (+1.1% vs +4.6%), and sense of smell by day 13 (–9.6% vs –5.6%). Significant improvement in peak nasal inspiratory flow was seen by day 2 (increase of 6.22 L/min vs 1.48 L/min for placebo; P = .03). Conclusion Mometasone furoate nasal spray 200 μg twice daily rapidly improves the symptoms of nasal polyposis, leading to lasting relief of most major symptoms within 2 (24 hours after the first dose) to 5 days of initiating therapy.