New Nasal Applicator / New Formulation - User Study

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: budesonide (Drug); Budesonide (Device); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Shaile Shah, MD, Principal Investigator, Affiliation: Allergy & Asthma Consultant, NJ, USA.
Bertil Andersson, Study Director, Affiliation: AstraZeneca

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).

Official title: 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).

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)

Secondary outcome:

Durability of device

Safety assessment via adverse events and clinical measurements

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: April 2002
Ending date: October 2002
Last updated: March 21, 2008