Title
New Nasal Applicator / New Formulation - User Study
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).
Phase
Phase 2Lead Sponsor
AstraZenecaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Seasonal Allergic RhinitisIntervention/Treatment
budesonide ...Study Participants
200The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
Current product
New type device
Inclusion Criteria: In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids. A documented history of at least one year of seasonal allergic rhinitis. A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout the study. Exclusion Criteria: Primary or secondary adrenal insufficiency Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator. A diagnosis of asthma requiring treatment as specified in the protocol.
