Beconase AQ (Beclomethasone Dipropionate Monohydrate Nasal) - Summary

BECONASE AQ SUMMARY

BECONASE AQ®
(beclomethasone dipropionate,
monohydrate)
Nasal Spray, 42 mcg
For Intranasal Use Only.
SHAKE WELL BEFORE USE.

Beclomethasone dipropionate, monohydrate, the active component of BECONASE AQ Nasal Spray, is an anti-inflammatory steroid having the chemical name 9-chloro-11(beta),17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, monohydrate.

BECONASE AQ Nasal Spray is indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis.

Results from 2 clinical trials have shown that significant symptomatic relief was obtained within 3 days. However, symptomatic relief may not occur in some patients for as long as 2 weeks. BECONASE AQ Nasal Spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. BECONASE AQ Nasal Spray should not be used in the presence of untreated localized infection involving the nasal mucosa.

BECONASE AQ Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal.

Clinical studies have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease.

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NEWS HIGHLIGHTS

Published Studies Related to Beconase AQ (Beclomethasone Nasal)

A randomized study comparing the effect of loratadine added to montelukast with montelukast, loratadine, and beclomethasone monotherapies in patients with chronic asthma. [2009.06]
CONCLUSION: In this study, the addition of loratadine to montelukast produced a small numerical, but not statistically significant, improvement in FEV(1) and, in general, no consistent improvement in other asthma endpoints. No improvement of montelukast + loratadine versus beclomethasone was seen in any endpoint.

A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity. [2008.12]
BACKGROUND: Inhaled corticosteroids (ICS) are recommended first-line therapy for the treatment of persistent asthma. However, reports from observational studies have suggested that the use of ICS may be associated with systemic adverse events, such as glaucoma and cataract (opacity of the lens) formation. OBJECTIVE: To compare two ICS over 1 year regarding the formation/progression of lenticular opacities in patients with asthma... CONCLUSIONS: Mean changes in LOCS III scores were very small in both groups. Treatment with ciclesonide 640 micro g/day or beclomethasone dipropionate 640 micro g/day for 1 year has a minimal impact on lenticular opacities development and/or progression.

Beclomethasone inhaler versus intravenous lidocaine in the prevention of postoperative airway and throat complaints: a randomized, controlled trial. [2008.01]
BACKGROUND AND OBJECTIVE: Previous reports indicate that inhaled corticosteroids attenuate airway inflammation. Beclomethasone inhaler was highly effective in the prevention of postoperative airway symptoms. Intravenous lidocaine prior to endotracheal intubation has also been shown to decrease the incidence of postoperative sore throat and cough. The aim of the present study was to compare the effect of beclomethasone inhaler with various clinically used dosages of intravenous lidocaine prior to endotracheal intubation on the incidence and severity of postoperative sore throat, cough, sputum, hoarseness, and dysphagia... CONCLUSION: Beclomethasone inhaler is comparable with intravenous lidocaine prior to intubation in decreasing postoperative sore throat and cough. In addition, beclomethasone inhaler decreases the incidence and severity of postoperative sputum.

Tolerability of high cumulative doses of the HFA modulite beclomethasone dipropionate/formoterol combination inhaler in asthmatic patients. [2008]
The corticosteroid beclomethasone dipropionate (BDP) has been formulated with the long acting beta agonist formoterol (BDP/formoterol 100 microg/6 microg, Foster) in a single inhaler using Modulite technology... The BDP/formoterol combination was well tolerated, and exhibited a safety profile generally similar to formoterol alone when administered in high doses to stable asthmatic patients.

Efficacy and safety of once or twice daily inhalation of extrafine HFA beclomethasone dipropionate in patients with mild to moderate asthma. [2007.11]
The relatively new chlorofluorocarbon-free solution preparation of beclomethasone dipropionate in hydrofluoroalkane (HFA-BDP) (Qvar, 3M Pharmaceuticals) generates an extra fine aerosol with a smaller particle size (mean mass aerodynamic diameter of 1.1 microm), drug deposition in the lung is more uniformly distributed, thus improving efficacy even at a low dose...

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Clinical Trials Related to Beconase AQ (Beclomethasone Nasal)

Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms [Completed]
To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation, compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young children with persistent symptoms of asthma.

Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children [Completed]
The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in 1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal awakening and utilization of rescue medication per day also will be evaluated. In addition, an exploratory evaluation will assess the comparability of the two devices (i. e., QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.

The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Inflammometry [Completed]
Background Chronic inflammation in peripheral airways plays an important role in the pathophysiology of asthma. Extrafine hydrofluoroalkane (HFA) beclometasone is distinguished from other ICS because of its fine aerosol characteristics. As a result, there is a greater extent of deposition of extrafine HFA-beclometasone in the peripheral airways. Therefore, extrafine HFA-beclometasone may have an extra anti-inflammatory effect in children with asthma.

Aim To analyse the potential extra anti-inflammatory effect of extrafine HFA-beclometasone compared to HFA-flucticasone in children with asthma by means of alveolar nitric oxide (NO) concentration and bronchial NO flux, inflammatory markers in exhaled breath condensate (EBC), and conventional parameters.

Method In a cross-over study design of 6 months, 33 children, aged 6-12 years, with doctor diagnosed mild persistent asthma, were treated with extrafine HFA-beclometasone inhaled from an autohaler and HFA-flucticasone inhaled from a discus. Primary outcome parameters of this study were; alveolar NO concentration and bronchial NO flux. Secondary outcome parameters were inflammatory markers in EBC, lung function parameters, symptoms, presence and duration of exacerbations and adverse effects. All parameters were recorded at baseline and after each treatment period.

Rosiglitazone Versus Theophylline in Asthmatic Smokers [Completed]
Asthmatic smokers display a blunted response to both inhaled and oral corticosteroid treatments and are at increased risk for exacerbations and near fatal asthma. The prevalence of smoking in asthmatics runs between 20-30%. Therefore, new, more efficacious treatments are required.

Recent work has demonstrated a mechanism which may explain steroid resistance. A commonly used drug called theophylline can reverse this steroid resistance in laboratory studies. Another commonly used drug, rosiglitazone can reverse smoking induced lung inflammation in laboratory studies.

The investigators aim to study the effects of these drugs on smoking asthmatics' lung function and other parameters including quality of life and asthma control.

A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps [Recruiting]

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