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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
Est. primary completion date
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


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, 

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