High strength extrafine pMDI beclometasone/formoterol (200/6 μg) is effective in asthma patients not adequately controlled on medium-high dose of inhaled corticosteroids

BMC Pulmonary Medicine

Research Article

Manuela Latorre¹  Pierluigi Paggiaro¹  Mario Scuri²  Stefano Petruzzelli²  Annamaria Muraro²  Helene Raptis²  Massimo Corradi³  Christian Gessner⁴  Zenon Siergiejko⁵ 

[1] Cardio-Thoracic and Vascular Department, University of Pisa, Ospedale di Cisanello, Via Paradisa 2, 56124, Pisa, Italy;Chiesi Farmaceutici, Parma, Italy;Department of Clinical and Experimental Medicine, University of Parma, Parma, Italy;Department of Respiratory Medicine, University of Leipzig, Germany & POIS Leipzig GbR, Leipzig, Germany;Respiratory System Diagnostics and Bronchoscopy Department, Medical University of Bialystok, Bialystok, Poland;

关键词: Asthma;    Asthma Control;    Formoterol;    Peak Expiratory Flow;    Mometasone;   

DOI  :  10.1186/s12890-016-0335-9

 received in 2016-03-07, accepted in 2016-11-24,  发布年份 2016

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2016