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).”

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).

Study Type: Interventional

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

Study Primary Completion Date: August 2002

Intervention(s) in this Clinical Trial

• Drug: budesonide
  • Current product
• Device: Budesonide
  • New type device
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Rhinocort
• Placebo Comparator: 2

Primary Measures

• Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)
  • Time Frame: 2 weekly
    

Secondary Measures

• Durability of device
  • Time Frame: End of study
    
• Safety assessment via adverse events and clinical measurements
  • Time Frame: 2 weekly
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Shaile Shah, MD Principal Investigator Allergy & Asthma Consultant, NJ, USA.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641979

Study ID Number: SD-005-0698

ClinicalTrials.gov Identifier: NCT00641979

Health Authority: United States: Food and Drug Administration