Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.