Rhinitis, sinusitis, and ocular diseasesEfficacy and safety of mometasone furoate nasal spray in nasal polyposis
Section snippets
Study design
A randomized, double-blind, double-dummy, placebo-controlled study was carried out in 44 medical centers worldwide in accordance with the Declaration of Helsinki and guidelines on Good Clinical Practices. The study protocol and statement of informed consent were reviewed and approved by an Institutional Review Board and Independent Ethics Committee.
Subjects who met eligibility criteria at the screening visit (day −14, visit 1) underwent a 14-day, single-blind, placebo run-in period to help
Subject disposition and characteristics
A total of 354 subjects were randomized. No clinically relevant differences in demographic characteristics among the 3 treatment groups were observed, with ≤25% of subjects having a history of mild asthma or perennial allergic rhinitis (Table I). Small differences in baseline bilateral polyp grade score were observed between treatment groups, with the majority of subjects having a total bilateral polyp grade score of 4 to 6. More than 90% of subjects had a moderate to severe baseline
Discussion
The objectives of medical therapy for nasal polyposis are to reduce or eliminate polyps, open the nasal airway, improve or restore the sense of smell, and prevent recurrence.9, 10 Although endoscopic sinus surgery has been shown to be effective in reducing polyp size and nasal blockage, at least temporarily,18 a randomized controlled study evaluating medical treatment (oral and topical corticosteroids) with or without surgical treatment in subjects with symptomatic nasal polyposis found that
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2022, Journal of Allergy and Clinical ImmunologyCitation Excerpt :We reached out to 24 manuscript authors asking for additional information or clarifications, 7 of whom responded, as noted in the Acknowledgments. Table III23–82 summarizes the characteristics of included studies and their participants. The trials enrolled 7176 participants (median across trials, 70; range, 18-748) aged 46.1 years on average (range of means, 31-54), and mean percentage of female subjects across studies was 40%.
Advances in chronic rhinosinusitis in 2020 and 2021
2022, Journal of Allergy and Clinical ImmunologyYardstick for the medical management of chronic rhinosinusitis
2022, Annals of Allergy, Asthma and ImmunologyCitation Excerpt :It is well summarized in various exhaustive recent publications.3-5 Focusing on double-blind, placebo-controlled studies after 1990 yielded 28 trials in patients with CRSwNP with or without previous sinus surgery.6-33 The trials included patients at different stages of disease ranging from unoperated polyposis to previously operated polyposis to postoperative therapy.
Ciliary beat frequency of in vitro human nasal epithelium measured with the simple high-speed microscopy is applicable for safety studies of nasal drug formulations
2020, Toxicology in VitroCitation Excerpt :However, there were no long-term changes in CBF when the clinically relevant dose was applied (Fig. 6). Mometasone furoate is an effective medical treatment for nasal polyposis improving congestion/obstruction and the return of a sense of smell (Small et al., 2005). The clinical trial for patients with acute, uncomplicated rhinosinusitis exhibited positive results with significant symptom improvements achieved (Kuna et al., 2014; Meltzer et al., 1998).
Nasal Polyposis and Aspirin-Exacerbated Respiratory Disease
2020, Immunology and Allergy Clinics of North America
Supported by a grant from the Schering-Plough Research Institute.
Disclosure of potential conflict of interest: Dr Small received research support from PO 1998 SAR Study, PO 1925 Polyp Study, PO 2573 Follow-Up to Polyp Study, PO 2683 Acute Rhinosinusitis, and PO 2692 Acute Rhinosinusitis. Dr Stryszak, Dr Staudinger, and Dr Danzig are employed by Schering-Plough. Dr Schenkel has consultant arrangements with Schering-Plough and Sanofi-Aventis; receives research support from Schering-Plough, Sanofi-Aventis, and Glaxo; and is on the speakers bureau for Schering-Plough, Sanofi-Aventis, and Glaxo. All other authors have no conflict of interest to disclose.