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

Primary Purpose

Allergic Rhinitis, Allergy, Growth

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
West Penn Allegheny Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Allergic Rhinitis focused on measuring Allergic Rhinitis, Allergy, Growth

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Allegheny General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
April 30, 2008
Sponsor
West Penn Allegheny Health System
Collaborators
Aventis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00189449
Brief Title
Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
Official Title
Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
Study Type
Observational

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
West Penn Allegheny Health System
Collaborators
Aventis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergy, Growth
Keywords
Allergic Rhinitis, Allergy, Growth

7. Study Design

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Skoner, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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