NCT00189449

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 1, 2008

Status Verified

April 1, 2008

First QC Date

September 12, 2005

Last Update Submit

April 30, 2008

Conditions

Allergic RhinitisAllergyGrowth

Keywords

Allergic RhinitisAllergyGrowth

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Rhinitis, AllergicHypersensitivity

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • David Skoner, MD

    West Penn Allegheny Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Completion

June 1, 2007

Last Updated

May 1, 2008

Record last verified: 2008-04

Locations

US(1)