Children, Perennial Allergic Rhinitis (PAR), l-t Growth

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

PHASE4

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2003-04-30

Brief Summary

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The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 months.

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Detailed Description

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Conditions

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Perennial 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

Budesonide

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Budesonide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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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 perennial allergic rhinitis.
* A positive response to a skin prick test for perennial allergens that must be present in the subject's environment.
* Height and weight within normal limits.

Exclusion Criteria

* Any disease which may affect growth
* Sexual development later than Tanner stage I.
* 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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No