Assess the Efficacy and Safety of Rhinocort Aqua

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

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-05-31

Brief Summary

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The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.

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Detailed Description

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Conditions

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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

Nasal Spray

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

16mg Nasal Spray

Budesonide

Intervention Type DRUG

32mg Nasal Spray

Budesonide

Intervention Type DRUG

64mg Nasal Spray

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Budesonide

16mg Nasal Spray

Intervention Type DRUG

Budesonide

32mg Nasal Spray

Intervention Type DRUG

Budesonide

64mg Nasal Spray

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Rhinocort AQUA 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 allergic rhinitis and a positive response to a skin prick test at Visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study.
* At randomisation having nasal symptom scores as defined by the protocol.

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

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No