Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients with Seasonal Allergic Rhinitis

Meda Pharmaceuticals Inc.0 个研究点目标入组 780 人开始时间: 2011年3月30日最近更新: 2012年3月19日

研究概览

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•Patients with moderate-to-severe rhinitis
•12-hour reflective Total Nasal Symptom Score (TNSS) of at least 8 out of a possible 12 on screening visit, and a congestion score of 2 or 3 on visit 1
•12-hour reflective TNSS of at least 8 on 3 separate symptom assessments during the lead-in period
•12-hour reflective nasal congestion score of 2 or 3 recorded on 3 separate symptom assessments during the lead-in period
•Instantaneous TNSS of 8 or more at time point zero
•At least 2-year history of SAR during spring allergy season
•Presence of IgE-mediated hypersensitivity to a local spring pollen, confirmed by a positive response to skin prick within the last year
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 98
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 705
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 28

•Presence on nasal examination of any mucosal erosion, nasal ulceration, or nasal septal perforation on screening visit or randomisation visit
•Nasal surgery or sinus surgery within the previous year
•Chronic sinusitis with more than 3 episodes per year
•Patients currently or during the previous 6-months on sublingual immunotherapy
•Female adolescents who were pregnant or nursing
•Patients receiving immunotherapy injections and not on stable maintenance regimen for at least 30 days before the first study visit

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