High strength extrafine pMDI beclometasone-formoterol 200-6 μg is effective in asthma patients not adequately controlled on medium-high dose of inhaled corticosteroidsReport as inadecuate




High strength extrafine pMDI beclometasone-formoterol 200-6 μg is effective in asthma patients not adequately controlled on medium-high dose of inhaled corticosteroids - Download this document for free, or read online. Document in PDF available to download.

BMC Pulmonary Medicine

, 16:180

Asthma and allergic disorders

Abstract

BackgroundA high strength of beclomethasone-formoterol fumarate BDP-FF in a pressurised metered dose inhaler pMDI, which contains extrafine BDP 200 μg-actuation and FF 6 μg-actuation has been developed to treat those asthmatics who are not adequately controlled on previous treatments.

MethodsA 12-week, randomized, double-blind, parallel group study was performed to compare the efficacy and safety of pMDI BDP-FF 200-6 two actuations bid with BDP 100 μg four actuation bid in a population of 376 randomized adult asthmatics not adequately controlled with high dose of inhaled corticosteroids ICS or medium dose of ICS plus long acting β2agonists LABA.

ResultsThe primary endpoint change from baseline over the entire treatment period in average pre-dose morning peak expiratory flow PEF demonstrated the superiority of BDP-FF over BDP monotherapy, with an adjusted mean difference of 19 L-min, which is above the minimal important clinical difference reported for this parameter. Overall, BDP-FF and BDP showed a similar improvement of symptom-based parameters and of the use of rescue medication after 3-month treatment. The safety profile of the two drugs was comparable, although BDP monotherapy, but not BDP-FF, slightly reduced the levels of serum cortisol.

ConclusionsThe study proved that pMDI BDP-FF 200-6 μg was superior to BDP alone in improving lung function with comparable safety profiles. Therefore it may be considered as an effective treatment for adults with asthma not adequately controlled with high dose of ICS monotherapy or medium dose of ICS-LABA combinations.

Trial registrationClinicalTrials.gov: NCT01577082, date 06-04-2012.

Electronic supplementary materialThe online version of this article doi:10.1186-s12890-016-0335-9 contains supplementary material, which is available to authorized users.

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Author: Pierluigi Paggiaro - Massimo Corradi - Manuela Latorre - Helene Raptis - Annamaria Muraro - Christian Gessner - Zenon Sierg

Source: https://link.springer.com/







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