Official Title: “A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase IIIb Study to Assess the Efficacy, Safety & Product Attributes of Rhinocort Aqua(Budesonide) Versus Placebo and FluticasonePropionate as an Active Comparator in Patients 12yrs Age &Older With SeasonalAllergicRhinitis”

The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.

Study Type: Interventional

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

Study Primary Completion Date: July 2003

Intervention(s) in this Clinical Trial

• Drug: Budesonide
• Drug: Fluticasone propionate
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Budesonide
• Active Comparator: 2
  • Fluticasone propionate
• Placebo Comparator: 3

Primary Measures

• To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
  • Time Frame: 2 weeks
    

Secondary Measures

• To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
  • Time Frame: 2 weeks
    
• To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
  • Time Frame: 2 weeks
    
• Safety assessment via adverse events and clinical measurements.
  • Time Frame: 2 & 4 weeks
    

Inclusion Criteria:

• At least a 2 year documented history of seasonal allergic rhinitis
• who, 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 positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of 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 specifies in the protocol.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 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

Michael E Ruff, MD Principal Investigator Pharmaceutical Research, Dallas, USA  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641680

Study ID Number: D5360C00005

ClinicalTrials.gov Identifier: NCT00641680

Health Authority: United States: Food and Drug Administration