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

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00189449
First received: September 12, 2005
Last updated: April 30, 2008
Last verified: April 2008
  Purpose

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.


Condition Phase
Allergic Rhinitis
Allergy
Growth
Phase 4

Study Type: Observational
Official Title: Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Estimated Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00189449

Locations
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
Aventis Pharmaceuticals
Investigators
Principal Investigator: David Skoner, MD West Penn Allegheny Health System
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189449     History of Changes
Other Study ID Numbers: IST Nasacort AQ NAS.US1.631, RC - 3421
Study First Received: September 12, 2005
Last Updated: April 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:
Allergic Rhinitis
Allergy
Growth

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014