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Review
. 2016 Oct;10(5):492-502.
doi: 10.1177/1753465816654442. Epub 2016 Jun 23.

High-dose beclometasone dipropionate/formoterol fumarate in fixed-dose combination for the treatment of asthma

Massimo Corradi  1 , Monica Spinola  2 , Stefano Petruzzelli  2 , Piotr Kuna  3
Affiliations
Review

High-dose beclometasone dipropionate/formoterol fumarate in fixed-dose combination for the treatment of asthma

Massimo Corradi et al. Ther Adv Respir Dis. 2016 Oct.

Abstract

The high-strength formulation of extrafine beclometasone dipropionate/formoterol fumarate (BDP/Form) 200/6 µg has been developed to step up inhaled corticosteroid treatment, without increasing the dose of the bronchodilator, in patients who are not controlled with previous therapies. Two clinical studies have evaluated efficacy of high-strength BDP/Form as compared with another high-dose fixed combination and BDP monotherapy. Overall, data show that BDP/Form 200/6 μg improves lung function and has beneficial effects on symptoms, use of rescue medication and asthma control, with an acceptable safety profile comparable with that of high-dose fluticasone propionate/salmeterol. Therefore, BDP/Form 200/6 μg could be considered as an effective and safe treatment for patients with asthma who are not adequately controlled with high doses of inhaled corticosteroid monotherapy or medium doses of inhaled corticosteroid/long-acting β2-agonist combinations.

Keywords: asthma; beclometasone dipropionate/formoterol fumarate; high-dose fixed combination; inhaled corticosteroid; long-acting β2-agonist.

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Conflict of interest statement

Conflict of interest statement: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Massimo Corradi has during the last 3 years received honoraria for lectures from Chiesi Farmaceutici, Italy. Piotr Kuna has during the last 3 years received honoraria for participating in advisory board meetings or giving lectures for the following companies: Adamed, Allergopharma, Almirall, AstraZeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Celon Pharma, Chiesi, FAES, GSK, HAL, Meda, MSD, Novartis, Pfizer, Polpharmex, Polpharma, Stallergen, Teva. Monica Spinola and Stefano Petruzzelli are full time Chiesi Farmaceutici employees.

Figures

Figure 1.
Figure 1.
Change from baseline in percentage of complete days without asthma symptoms in study CT01. *p < 0.05. BDP, beclometasone dipropionate; BDP/Form, beclometasone dipropionate/formoterol fumarate; FP/Salm, fluticasone propionate/salmeterol.
Figure 2a and b.
Figure 2a and b.
Change from baseline in asthma control-related parameters in study CT01. Bars represent 95% confidence interval. BDP, beclometasone dipropionate; BDP/Form, beclometasone dipropionate/formoterol fumarate.
Figure 3.
Figure 3.
Change from baseline in lung function parameters in the FORCE study. (a) morning PEF; (b) evening PEF; (c) FEV1 (post-hoc analysis taking into account the results of the reversibility test at screening). Data are reported as mean ± standard deviation. BDP, beclometasone dipropionate; FEV1, forced expiratory volume in 1 second; Form, formoterol fumarate; PEF, peak expiratory flow.
See this image and copyright information in PMC

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