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Rhinocort Aqua (Budesonide Nasal) - Summary



Nasal Spray 32 mcg

For Intranasal Use Only. Budesonide, the active ingredient of RHINOCORT AQUA® Nasal Spray, is an anti-inflammatory synthetic corticosteroid.

RHINOCORT AQUA Nasal Spray is indicated for the management of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older.

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Published Studies Related to Rhinocort Aqua (Budesonide Nasal)

Budesonide quantification by HPLC coupled to atmospheric pressure photoionization (APPI) tandem mass spectrometry. Application to a comparative systemic bioavailability of two budesonide formulations in healthy volunteers. [2011.02.01]
In the present study, a novel, fast, sensitive and robust method to quantify budesonide in human plasma using 3-keto-desogestrel as the internal standard (IS) is described. The analyte and the IS were extracted from human plasma by liquid-liquid extraction (LLE) using ether... Since the 90% CI for both C(max), AUC(last) and AUC(0-inf) were within the 80-125% interval proposed by the Food and Drug Administration and ANVISA, it was concluded that budesonide 64 mug/dose nasal spray was bioequivalent to Budecort Acqua(R) 64 mug/dose nasal spray, according to both the rate and extent of absorption.

The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. [2009.03]
OBJECTIVES: To evaluate whether nasal administration of budesonide in adults with chronic rhinosinusitis for 30 days suppresses adrenal function and to assess its clinical efficacy... CONCLUSION: Our findings suggest that using budesonide nasal wash may be clinically effective in decreasing the symptoms of chronic rhinosinusitis and does so without suppression of the hypothalamic-pituitary-adrenal axis in patients with chronic rhinosinusitis.

Long-term comparison of sublingual immunotherapy vs inhaled budesonide in patients with mild persistent asthma due to grass pollen. [2009.01]
BACKGROUND: Few studies have compared the effects of immunotherapy and inhaled steroids. The main limitation of such studies is the long duration required to fully appreciate the effects of immunotherapy. OBJECTIVE: To compare the effects of inhaled budesonide and sublingual immunotherapy (SLIT) in mild persistent asthma for up to 5 years... CONCLUSION: In patients with grass pollen-induced asthma, in the long term SLIT was equally effective as inhaled budesonide in treating bronchial symptoms and provided an additional benefit in treating rhinitis symptoms and bronchial hyperresponsiveness.

Effects of topical formoterol alone and in combination with budesonide in a pollen season model of allergic rhinitis. [2007.06]
BACKGROUND: beta(2)-Agonists may exert mast cell stabilizing and anti-plasma exudation effects. While available data suggest no or only marginal effects of beta(2)-agonists on symptoms of allergic rhinitis, little is known about whether these drugs may add to the efficacy of anti-rhinitis drugs. OBJECTIVE: To examine effects of a beta(2)-agonist, alone and in combination with an intranasal glucocorticosteroid, on symptoms and signs of allergic rhinitis... CONCLUSION: The present dose of formoterol does not affect symptoms and inflammatory signs of allergic rhinitis and does not add to the efficacy of topical budesonide.

Growth velocity in children with perennial allergic rhinitis treated with budesonide aqueous nasal spray. [2006.05]
BACKGROUND: Recent guidelines recommend intranasal corticosteroids as first-line treatment for managing persistent symptoms of moderate to severe allergic rhinitis (AR). However, in children, long-term continual treatment with corticosteroids has raised concerns about potential growth suppression. OBJECTIVE: To evaluate the effects of the recommended once-daily dose of budesonide aqueous nasal spray on growth velocity, as measured with stadiometry, in children with perennial AR... CONCLUSIONS: Treatment with budesonide aqueous nasal spray, 64 microg once daily, for 1 year did not suppress growth velocity compared with placebo and was well tolerated in prepubertal children with perennial AR.

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Clinical Trials Related to Rhinocort Aqua (Budesonide Nasal)

Assess the Efficacy and Safety of Rhinocort Aqua [Completed]
The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.

Rhinocort Aqua Versus Placebo and Fluticasone Propionate [Completed]
The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.

Adults With Moderate to Severe Asthma [Completed]
A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

New Nasal Applicator / New Formulation - User Study [Completed]
The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).

New Version Pulmicort Turbuhaler USA Children [Completed]
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

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Page last updated: 2011-12-09

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