New Nasal Applicator / New Formulation - User Study

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Placebo; Device: Budesonide

• Registration Number: NCT00641979
• Lead Sponsor: AstraZeneca

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2002-08
• Study Completion: 2002-08
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Budesonide	Rhinocort

Primary Outcome Measures

Name	Time	Method
Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)	2 weekly

Secondary Outcome Measures

Name	Time	Method
Durability of device	End of study
Safety assessment via adverse events and clinical measurements	2 weekly