Status:
COMPLETED
Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis
Lead Sponsor:
West Penn Allegheny Health System
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Allergic Rhinitis
Allergy
Eligibility:
All Genders
6-13 years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
June 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00189449
End Date
June 1 2007
Last Update
May 1 2008
Active Locations (1)
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1
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212