Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis

April 30, 2008 updated by: West Penn Allegheny Health System
Seasonal/perennial allergic rhinitis (SAR/PAR) is a common childhood illness. One of the leading therapies for the treatment of SAR/PAR is intranasally inhaled corticosteroids (ICS). One of the major long-term safety concerns is whether ICS interferes with normal growth in allergic rhinitis children. Recent evidence suggests that nasal ICS may cause decreased growth. However, the effect of nasal ICS on long-term growth and the attainment of final adult height is unknown. Another potential systemic adverse effect of ICS use is suppression of the hypothalamic-pituitary-adrenal axis function. The primary hypothesis of this study is that triamcinolone acetonide aqueous nasal spray (TAA) will have no effect on measured adult height in relation to target adult height in children with allergic rhinitis.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male/Female aged 6-13 years of age
  • Diagnosis of SAR/PAR, with symptoms within the past 3 months
  • Positive skin test to inhalant allergen with negative saline control
  • No previous use of intranasal inhaled, oral, IV or topical steroid use within past 6 months.
  • If the subject has asthma, only mild intermittent (per NAPP) guidelines treated with PRN bronchodilator

Exclusion Criteria:

  • screening height outside the 5th and 95th percentiles
  • History of abnormal growth
  • Any other chronic condition beside allergic rhinitis or mild intermittent asthma
  • Subject who has insufficient allergic rhinitis symptoms to require daily therapy during the trial.
  • Subject with a known hypersensitivity to any active ingredients or excipents in the study medications
  • Subject with nasal candidiasis, acute or chronic sinusitis, significant nasal polyposis (impairs nasal breathing), or other gross anatomical deformity of the nose sufficient to impair nasal breathing (e.g., deviated septum)
  • Subjects with a history of substance abuse, mental illness or retardation
  • Subjects with a history or presence of glaucoma or posterior subcapsular cataract
  • Subjects with nocturnal enuresis.
  • Use of Theophylline, Intal/Tilade or leukotriene modifiers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Penn Allegheny Health System

Collaborators

Aventis Pharmaceuticals

Investigators

  • Principal Investigator: David Skoner, MD, West Penn Allegheny Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

May 1, 2008

Last Update Submitted That Met QC Criteria

April 30, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IST Nasacort AQ NAS.US1.631
  • RC - 3421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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