New Nasal Applicator / New Formulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2002-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Rhinocort

Group Type EXPERIMENTAL

budesonide

Intervention Type DRUG

Current product

Budesonide

Intervention Type DEVICE

New type device

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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budesonide

Current product

Intervention Type DRUG

Budesonide

New type device

Intervention Type DEVICE

Placebo

Intervention Type DRUG

Other Intervention Names

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Rhinocort AQUA Rhinocort Aqua

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No