BECONASE AQ SUMMARY
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.
Published Studies Related to Beconase AQ (Beclomethasone Nasal)
Randomised clinical trial: preventive treatment with topical rectal beclomethasone dipropionate reduces post-radiation risk of bleeding in patients irradiated for prostate cancer. [2011.09]
BACKGROUND: Radiotherapy is an established treatment modality for prostate cancer; however, up to a third of patients develops a radiation-induced proctopathy. AIM: To assess the effect of topical beclomethasone dipropionate (BDP) in the prevention of radiation-induced proctopathy in patients undergoing radiotherapy for prostate cancer through a double-blind, placebo-controlled, randomised trial... CONCLUSIONS: Preventive treatment with topical rectal BDP during radiotherapy for prostate cancer significantly reduces the risk of rectal bleeding and radiation-induced mucosal changes and improves patient's quality of life, but does not influence other radiation-induced symptoms. (c) 2011 Blackwell Publishing Ltd.
Effect of Beclomethasone Nasal Spray on Intraocular Pressure in Ocular Hypertension or Controlled Glaucoma. [2011.06.28]
PURPOSE: To evaluate the effect of 6 weeks administration of beclomethasone nasal spray on intraocular pressure (IOP) in patients with ocular hypertension or controlled primary open-angle glaucoma... CONCLUSIONS: Patients with ocular hypertension and primary open-angle glaucoma showed no evidence of IOP elevation after 6 weeks use of beclomethasone nasal spray.
Beclomethasone dipropionate in Crohn's ileitis: a randomised, double-blind trial. [2011.06]
BACKGROUND: Steroids, the mainstay of Crohn's disease treatment, have been associated with systemic side effects. AIM: To evaluate the efficacy and tolerability of beclomethasone dipropionate for maintaining remission induced by a short course of systemic steroids in patients with Crohn's ileitis with or without right colonic involvement... CONCLUSION: These results demonstrate that beclomethasone dipropionate significantly reduces the relapse rate in post-active Crohn's ileitis patients compared with placebo after induction of remission with a short course of systemic steroids, and is well tolerated. Copyright (c) 2010 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomised, double-blind, placebo-controlled trial. [2011.02.19]
BACKGROUND: Daily inhaled corticosteroids are an effective treatment for mild persistent asthma, but some children have exacerbations even with good day-to-day control, and many discontinue treatment after becoming asymptomatic. We assessed the effectiveness of an inhaled corticosteroid (beclomethasone dipropionate) used as rescue treatment... INTERPRETATION: Children with mild persistent asthma should not be treated with rescue albuterol alone and the most effective treatment to prevent exacerbations is daily inhaled corticosteroids. Inhaled corticosteroids as rescue medication with albuterol might be an effective step-down strategy for children with well controlled, mild asthma because it is more effective at reducing exacerbations than is use of rescue albuterol alone. Use of daily inhaled corticosteroid treatment and related side-effects such as growth impairment can therefore be avoided. FUNDING: National Heart, Lung and Blood Institute. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Rapid onset of bronchodilation with formoterol/beclomethasone Modulite and formoterol/budesonide Turbuhaler as compared to formoterol alone in patients with COPD. [2011.02]
In the present study, we examined whether there is a difference in the onset of bronchodilatation between formoterol/beclomethasone 12/200 mug Modulite and formoterol/budesonide 9/320 mug Turbuhaler in patients with COPD. We enrolled 28 patients with stable COPD... This study confirms the rapid effect of the inhaled corticosteroid component when combined with formoterol and indicates that the onset of bronchodilation of formoterol/beclomethasone Modulite and formoterol/budesonide Turbuhaler are similar and greater than formoterol alone in patients with COPD.
Clinical Trials Related to Beconase AQ (Beclomethasone Nasal)
A Study Evaluating the Effect of Inhaled and Nasal Corticosteroids on Short Term Growth in Pediatric Subjects With Mild Asthma & Allergic Rhinitis [Not yet recruiting]
This study will provide the clinicians guidance on the safest combination of inhaled and
nasal corticosteroids for children with mild asthma and allergic rhinitis respectively;
however, one safety concern is that these products are independently known to have
dose-related effects on short term and intermediate term growth. Knemometry is a non
invasive technique for measuring short-term lower leg growth in children and is currently
the method of choice in growth studies of short duration. Subjects will be seen on a weekly
basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.
Study Evaluating With Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth in Pediatric Subjects w/Asthma [Recruiting]
Children with mild persistent asthma that have asthma symptoms once or twice a week and use
a daily controller, while children with mild intermittent asthma rarely have asthma symptoms
and do not use a daily controller. Inhaled corticosteroids are the standard treatment for
mild peristent asthma. The purpose of this study is to measure children rate of growth
while on different inhaled corticosteroids.
Effects of QVAR in Smokers With Asthma [Not yet recruiting]
We hypothesize that extra-fine particle treatment with HFA-QVAR will be superior in
improving small airways dysfunction, especially in ex-smokers and smokers with asthma.
To investigate this, we will perform a study comparing the efficacy of extra-fine particle
HFA-QVAR 200 µg b. i.d. to an equipotent dose of course particle HFA-beclomethasone
(HFA-Clenil) 400 µg b. i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in
ex-smokers and smokers with asthma.
Study design: This study will be an open-label, randomised, three-way cross-over, two-center
study. 20 smokers and 20 ex-smokers with asthma will receive the following treatments for
Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD) [Recruiting]
Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly
treated with inhaled steroids, an optional treatment according to textbooks and guidelines .
However, the evidence supporting this treatment in spontaneously breathing infants is
limited, and based on only two randomized, placebo-controlled trials (RCT) with relative
small number of infants . The Cochrane review concluded that these studies do not allow firm
conclusions with regard to the efficacy of inhaled steroids in non-ventilated infants .
Thus, there is no doubt that there is a need for more RCT in order to ascertain the role of
inhaled steroids in infants with BPD. Because of its physical properties that theoretically
make QVAR an attractive therapy in infants and studies showing it to be as effective as and
with similar safety profile as other inhaled steroids in children, the investigators
hypothesized that inhaled QVAR will be an effective therapy in infants with BPD.
Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children [Recruiting]
The purpose of this clinical study is to compare the improvement in breathing of single
administration of CHF 1535 50/6 pMDI (fixed combination of a corticosteroid drug
beclomethasone 50 µg + formoterol 6 µg/puff, 2 inhalations, total dose 100/12 µg) given with
spacer versus free combination of beclomethasone 50 µg/puff pMDI (2 inhalations, total dose
100 µg) given with spacer plus formoterol 6 µg/puff pMDI (2 inhalations, total dose 12 µg)
given with spacer in terms of FEV1 from 0 to 12 hours in asthmatic children.
Additionally the study aims to evaluate the effects of doses of CHF 1535 pMDI compared to
placebo and the effect on other lung function parameters, to assess the safety and
tolerability of CHF 1535 dosages in children.
Page last updated: 2011-12-09