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

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          Abstract

          Background

          A 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.

          Methods

          A 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 β 2agonists (LABA).

          Results

          The 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.

          Conclusions

          The 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 registration

          ClinicalTrials.gov: NCT01577082, date 06/04/2012.

          Electronic supplementary material

          The 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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          Most cited references18

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          Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study.

          K. F. Rabe, P Vermeire, J. Soriano … (2000)
          Asthma management guidelines provide recommendations for the optimum control of asthma. This survey assessed the current levels of asthma control as reported by patients, which partly reflect the extent to which guideline recommendations are implemented. Current asthma patients were identified by telephone by screening 73,880 households in seven European countries. Designated respondents were interviewed on healthcare utilization, symptom severity, activity limitations and asthma control. Current asthma patients were identified in 3,488 households, and 2,803 patients (80.4%) completed the survey. Forty-six per cent of patients reported daytime symptoms and 30% reported asthma-related sleep disturbances, at least once a week. In the past 12 months, 25% of patients reported an unscheduled urgent care visit, 10% reported one or more emergency room visits and 7% reported overnight hospitalization due to asthma. In the past 4 weeks, more patients had used prescription quick-relief medication (63%) than inhaled corticosteroids (23%). Patient perception of asthma control did not match their symptom severity; approximately 50% of patients reporting severe persistent symptoms also considered their asthma to be completely or well controlled. The current level of asthma control in Europe falls far short of the goals for long-term asthma management. Patients' perception of asthma control is different from their actual asthma control.
          Article 0 comments Cited 164 times – based on 0 reviews     Review now
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            Update on asthma control in five European countries: results of a 2008 survey.

            B Gueron, Dale R. Walters, K Annunziata … (2010)
            The 2006 European National Health and Wellness Survey (NHWS) showed that a large proportion of asthmatics had uncontrolled asthma. The current analysis estimated the prevalence of asthma and asthma control (Asthma Control Test™ (ACT); QualityMetric Inc., Lincoln, RI, USA) in five European countries using the 2008 NHWS. Health-related quality of life (HRQoL), using the Short Form-12 (SF-12) health survey, and work productivity/activity impairment were assessed. Of 3,619 respondents aged ≥18 yrs, the prevalence of self-reported physician diagnosis of asthma was 6.1% (15 million people); 56.6% of treated asthmatics were not well-controlled (NWC; ACT score ≤19). Individual components of the ACT showed that, compared with at least well-controlled patients (ALWC; ACT score ≥20), NWC patients had activity limitations at least some of the time (40.8% versus 1.5%, p<0.001), were breathless ≥3 times per week (72.5% versus 5.4%, p<0.001), suffered sleep difficulties due to asthma at least once per week (60.3% versus 4.6%, p<0.001) and required rescue medication ≥2-3 times per week (77.4% versus 15.9%, p<0.001). NWC patients had also received more healthcare contact in the past 6 ;months, including hospitalisation (17.4% versus 9.9%, p<0.001). The SF-12 physical and mental summary scores were 7.46 and 4.73 points higher, respectively, for ALWC patients compared with NWC patients (p<0.001). ALWC patients reported less absenteeism (5.5% versus 12.2%) and work impairment (15.4% versus 30.0%) than NWC patients (both p<0.001). The proportion of asthmatics with NWC asthma has not improved since 2006. ALWC asthma is associated with a significant positive impact on healthcare resource use, HRQoL and work productivity.
            Article 0 comments Cited 52 times – based on 0 reviews     Review now
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              What are minimal important changes for asthma measures in a clinical trial?

              J ZHANG, B.l Barber, N.c Santanello … (1999)
              Article 0 comments Cited 32 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Pierluigi Paggiaro: 050-995365 , pierluigi.paggiaro@unipi.it
                Journal
                Journal ID (nlm-ta): BMC Pulm Med
                Journal ID (iso-abbrev): BMC Pulm Med
                Title: BMC Pulmonary Medicine
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2466
                Publication date (Electronic): 9 December 2016
                Publication date PMC-release: 9 December 2016
                Publication date Collection: 2016
                Volume: 16
                Electronic Location Identifier: 180
                Affiliations
                [1 ]Cardio-Thoracic and Vascular Department, University of Pisa, Ospedale di Cisanello, Via Paradisa 2, 56124 Pisa, Italy
                [2 ]Department of Clinical and Experimental Medicine, University of Parma, Parma, Italy
                [3 ]Chiesi Farmaceutici, Parma, Italy
                [4 ]Department of Respiratory Medicine, University of Leipzig, Germany & POIS Leipzig GbR, Leipzig, Germany
                [5 ]Respiratory System Diagnostics and Bronchoscopy Department, Medical University of Bialystok, Bialystok, Poland
                Article
                Publisher ID: 335
                DOI: 10.1186/s12890-016-0335-9
                PMC ID: 5148913
                PubMed ID: 27938358
                SO-VID: 0e7bde7e-4c0e-4b26-971c-7ca88b3f9e32
                Copyright © © The Author(s). 2016
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 7 March 2016
                Date accepted : 24 November 2016
                Categories
                Subject: Research Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2016

                ScienceOpen disciplines: Respiratory medicine
                Data availability:
                ScienceOpen disciplines: Respiratory medicine

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