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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189449
• Other study ID #: IST Nasacort AQ NAS.US1.631
• Secondary ID: RC - 3421
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: April 30, 2008
• Est. completion date: June 2007

Study information

• Verified date: April 2008
• Source: West Penn Allegheny Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 13 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergy
• Growth
• Rhinitis

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
West Penn Allegheny Health System	Aventis Pharmaceuticals

Country where clinical trial is conducted

United States,