Rhinocort Aqua Versus Placebo and Fluticasone Propionate

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641680
• Other study ID #: D5360C00005
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2008
• Last updated: January 21, 2011
• Start date: April 2003
• Est. completion date: July 2003

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Budesonide

• Fluticasone propionate

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.		2 weeks
Secondary	To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.		2 weeks
Secondary	To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.		2 weeks
Secondary	Safety assessment via adverse events and clinical measurements.		2 & 4 weeks