Rhinocort Aqua Versus Placebo and Fluticasone Propionate

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Budesonide; Drug: Fluticasone propionate; Drug: Placebo

• Registration Number: NCT00641680
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2003-07
• Study Completion: 2003-07
• 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: 750

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Budesonide	Budesonide
2	Fluticasone propionate	Fluticasone propionate
3	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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