New Nasal Applicator / New Formulation - User Study

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Seasonal Allergic Rhinitis

Treatments

Drug: Placebo

Device: Budesonide

Drug: budesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00641979

SD-005-0698

D5360C00698

Details and patient eligibility

About

The 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).

Enrollment

200 estimated patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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.