Rhinocort Aqua Versus Placebo and Fluticasone Propionate

NCT ID: NCT00641680

Last Updated: 2011-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2003-07-31

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Budesonide

Group Type: EXPERIMENTAL

Budesonide

Intervention Type: DRUG

2

Fluticasone propionate

Group Type: ACTIVE_COMPARATOR

Fluticasone propionate

Intervention Type: DRUG

3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Budesonide

Intervention Type: DRUG

Fluticasone propionate

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Rhinocort AQUA; Flonase®

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

Michael E Ruff, MD

Role: PRINCIPAL_INVESTIGATOR

Pharmaceutical Research, Dallas, USA

Other Identifiers

D5360C00005

Identifier Type: -

Identifier Source: org_study_id