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Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis

2014-07-23 21:08:35 | BioPortfolio

Summary

Primary Objective:

To evaluate the effect of a 6-week treatment with triamcinolone acetonide aqueous nasal spray (TAA-AQ) 110 μg and 220 μg once daily (QD) versus placebo on basal HPA axis function as measured by serum cortisol area under the curve over a 24-hour period [AUC(0-24 hr)] in children [≥ 2 to < 12 years of age] with allergic rhinitis (AR)

Description

The study consists of a run-in single-blind period followed by an approximately 6-week double-blind treatment period. During the screening period subjects will take single-blind placebo nasal spray QD in the morning to enable them to practice their intranasal application technique with the nasal spray (1 actuation/nostril) and to test subject's compliance with their investigational product dosing regimen.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Rhinitis, Allergic, Perennial and/or Seasonal

Intervention

TRIAMCINOLONE ACETONIDE (NASACORT AQ), Placebo

Location

Sanofi-Aventis Administrative Office
Bridgewater
New Jersey
United States

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:35-0400

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Medical and Biotech [MESH] Definitions

Allergic rhinitis that occurs at the same time every year. It is characterized by acute CONJUNCTIVITIS with lacrimation and ITCHING, and regarded as an allergic condition triggered by specific ALLERGENS.

Antigens from the house dust mites (DERMATOPHAGOIDES), mainly D. farinae and D. pteronyssinus. They are proteins, found in mite feces or mite extracts, that can cause ASTHMA and other allergic diseases such as perennial rhinitis (RHINITIS, ALLERGIC, PERENNIAL) and atopic dermatitis (DERMATITIS, ATOPIC). More than 11 groups of Dermatophagoides ALLERGENS have been defined. Group I allergens, such as Der f I and Der p I from the above two species, are among the strongest mite immunogens in humans.

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A long-acting, non-sedative antihistaminic used in the treatment of seasonal allergic rhinitis, asthma, allergic conjunctivitis, and chronic idiopathic urticaria. The drug is well tolerated and has no anticholinergic side effects.

A group of symptoms that are two- to three-fold more common in those who work in large, energy-efficient buildings, associated with an increased frequency of headaches, lethargy, and dry skin. Clinical manifestations include hypersensitivity pneumonitis (ALVEOLITIS, EXTRINSIC ALLERGIC); allergic rhinitis (RHINITIS, ALLERGIC, PERENNIAL); ASTHMA; infections, skin eruptions, and mucous membrane irritation syndromes. Current usage tends to be less restrictive with regard to the type of building and delineation of complaints. (From Segen, Dictionary of Modern Medicine, 1992)

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