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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)
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Rhinitis, Allergic, Perennial and/or Seasonal
TRIAMCINOLONE ACETONIDE (NASACORT AQ), Placebo
Sanofi-Aventis Administrative Office
Published on BioPortfolio: 2014-07-23T21:08:35-0400
A Study Comparing the Bioequivalence of Triamcinolone Acetonide Aqueous Nasal Spray (Apotex, Inc.) to That of Nasacort® AQ Nasal Spray (Sanofi-Aventis Pharmaceutical Products, Inc.) In the Treatment of Seasonal Allergic Rhinitis
A randomized, double-blind, placebo-controlled parallel-group study, comparing the bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of Nasacort® AQ nas...
The purposes of this study are: - To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared with placebo in children 2-5 years of age with perennial...
To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious Rhinit...
Primary Objective: - To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by r...
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...
The coexistence of asthma and allergic rhinitis (AR) and its distinct association with obesity have been reported. However, few studies have differentiated the two types of AR, i.e., perennial (PAR) a...
Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study.
Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation...
Allergic Rhinitis Control Test(ARCT) has been validated in allergic rhinitis(AR) step-up pharmacotherapy management approach.
Several studies demonstrated that placebo treatment may have a significant impact on many different symptoms. While in the traditional view concealment of the placebo is essential, recent studies repo...
Endotyping chronic rhinitis has proven hardest for the subgroup of non-allergic rhinitis (NAR) patients. While IgE-related inflammation is typical for allergic rhinitis (AR), no markers have been foun...
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.
An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.
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)
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...