Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
Information source: Allegheny General Hospital
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis; Allergy; Growth
Phase: Phase 4
Status: Completed
Sponsored by: Allegheny General Hospital Official(s) and/or principal investigator(s):
David Skoner, MD, Principal Investigator, Affiliation: Allegheny General Hospital
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.
Clinical Details
Official title: Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
Study design: Longitudinal, Defined Population, Retrospective/Prospective Study
Eligibility
Minimum age: 6 Years.
Maximum age: 13 Years.
Gender(s): Both.
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.
Locations and Contacts
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States
Additional Information
Ending date: June 2007
Last updated: October 1, 2007
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