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Completed

NCT Number: NCT00641212

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

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.

Completed

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Key information

Conditions

Perennial Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Budesonide

Drug

Other names: Rhinocort AQUA

Placebo

Drug

Primary outcomes

  1. Change in height over a 12 month period

    Time frame: 3 monthly

Secondary outcomes

  1. Change in growth velocity over a 12 month period.

    Time frame: 3 monthly

  2. Other safety - assessed by adverse event query

    Time frame: 3 monthly

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Long-Term Treatment With Rhinocort Aqua (Budesonide) Nasal Spray in Children With Perennial Allergic Rhinitis.

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Mar 24, 2008
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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