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)
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.
Drug Interaction Study Between Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers [Recruiting]
Patients with human immunodeficiency virus (HIV) and respiratory disease commonly require
protease inhibitors (PIs) and orally inhaled corticosteroids. Inhaled corticosteroids alone
do not generally cause systemic adverse effects because of low systemic bioavailability, but
the combination of inhaled fluticasone and various PIs has led to increased systemic
fluticasone levels and multiple cases of secondary adrenal insufficiency. A study in
healthy volunteers showed > 350-fold increase in fluticasone area under the curve when
ritonavir (RTV) 100mg twice daily was coadministered with intranasal fluticasone compared to
intranasal fluticasone alone. The mechanism of this drug interaction is presumably
secondary to PI inhibition of cytochrome P450 3A4, the enzyme responsible for fluticasone
metabolism. As a result, inhaled fluticasone is not recommended in combination with most
PIs unless the benefit outweighs the risk. One possible alternative to fluticasone is
inhaled beclomethasone, which has not been studied in combination with PIs. Although
beclomethasone also undergoes metabolism via CYP3A4 in vitro to its more active metabolite,
beclomethasone-17-monopropionate, it appears to be largely hydrolyzed by esterases in vivo.
Furthermore, the pharmacokinetic properties of beclomethasone-17-monopropionate, such as
relatively short half-life, low maximum plasma concentration, and low volume of
distribution, suggest that systemic accumulation leading to significant adverse effects is
unlikely even in the presence of a CYP3A4 inhibitor such as a PI.
In this open-label study, 46 subjects will receive inhaled beclomethasone for 6 weeks from
Days 1 to 42. Subjects will be randomized into 1 of 3 groups, such that from Days 15 to 42,
18 subjects will add no additional study drugs, 14 subjects will add RTV 100mg twice daily,
and 14 subjects will add DRV/r 600/100mg twice daily. Pharmacokinetic sampling for
beclomethasone and beclomethasone-17-monopropionate levels will occur on Days 14 and 28.
Pre-cosyntropin cortisol levels and a low-dose adrenocorticotropic hormone (ACTH)
stimulation test will be performed on all subjects on Days 1, 14, 28, and 42. Data from
this investigation will determine whether RTV and/or DRV/r, potent CYP 3A4 inhibitors, alter
the pharmacokinetics of beclomethasone and its active metabolite,
beclomethasone-17-monopropionate (primary objective), and whether or not a possible increase
in systemic bioavailability of beclomethasone and beclomethasone-17-monopropionate alters
pre-cosyntropin cortisol levels and responses to ACTH stimulation test over a 4-week period
(secondary objective). Results from this investigation will provide pharmacokinetic and
pharmacodynamic data to assist clinicians in determining whether inhaled beclomethasone is
an appropriate option in HIV-infected patients requiring concomitant therapy with an inhaled
corticosteroid and PIs.
Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis [Recruiting]
Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as
symptomatic treatment of upper respiratory infections without evidence of efficacy.
The purpose of this study is to evaluate the efficacy of beclomethasone (administered by
nebuliser twice a day) in preventing viral wheezing in pre-school children who had had
episodes in the preceding 12 months.
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD) [Recruiting]
Use of an oral topically-active glucocorticoid with limited side effects will control the
gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children [Recruiting]
Page last updated: 2011-12-09