BDP/formoterol MART asthma exacerbation benefit increases with blood eosinophil level

A number of studies have evaluated the effectiveness of a “Maintenance And Reliever Therapy” (MART) regimen combining in a single inhaler the rapid-acting, long-acting β2-agonist (LABA) formoterol fumarate (FF) with an inhaled corticosteroid (ICS) in asthma. Such a regimen is now established for the treatment of moderate-to-severe asthma in adolescents and adults in many guidelines. Furthermore, rescue short-acting β2-agonists (SABAs) are no longer recommended as sole therapy even for patients with mild asthma, and an ICS/FF combination used as needed is the preferred reliever therapy

Determinants and impact of suboptimal asthma control in Europe : The INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study

Acknowledgements We are grateful to THERAmetrics for the study management, data collection and analysis. The authors would like to thank the following investigators for their contribution (>30 patients enrolled): F. Fohler, A.G. Haider, J. Hesse-Tonsa, J. Messner, W. Pohl (Austria); G. Joos, J.L. Halloy, R. Peche, H. Simonis, P. Van den Brande (Belgium); B. Bugnas, J.M. Chavaillon, P. Debove, S. Dury, L. Mathieu, O. Lagrange, A. Prudhomme, S. Verdier (France); A. Benedix, O. Kestermann, A. Deimling, G. Eckhardt, M. Gernhold, V. Grimm-Sachs, M. Hoefer, G. Hoheisel, C. Stolpe, C. Schilder, M. John, J. Uerscheln, K.H. Zeisler (Germany); A. Chaniotou, P. Demertzis, V. Filaditaki-Loverdou, A. Gaga, E. Georgatou-Papageorgiou, S. Michailidis, G. Pavkalou, M. Toumpis (Greece); K. Csicsari, K. Hajdu, M. Póczi, M. Kukuly, T. Kecskes, C. Hangonyi, J. Schlezak, E. Takács, M. Szabo,G. Szabó, C. Szabo (Hungary); G.W. Canonica, W. Castellani, A. Cirillo, M.P. Foschino Barbaro, M. Gjomarkaj, G. Guerra, G. Idotta, D. Legnani, M. Lo Schiavo, R. Maselli, F. Mazza, S. Nutini, P. Paggiaro, A. Pietra, O. Resta, S. Salis, N.A. Scichilone, M.C. Zappa, A. Zedda (Italy); M. Goosens, R. Heller, K. Mansour, C. Meek, J. van den Berg (The Netherlands); A. Antczak, M. Faber, D. Madra-Rogacka, G. Mincewicz, M. Michnar, D. Olejniczak, G. Pulka, Z. Sankowski, K. Kowal, I. Krupa-Borek, B. Kubicka Kozik, K. Kuczynska, P. Kuna, A. Kwasniewski, M. Wozniak (Poland); F. Casas Maldonado, C. Cisneros, J. de Miguel Díez, L.M. Entrenas Costa, B. Garcìa-Cosio, M.V. Gonzales, L. Lores, M. Luengo, C. Martinez, C. Melero, I. Mir, X. Munoz, A. Pacheco, V. Plaza, J. Serra, J. Serrano, J.G. Soto Campos (Spain); T. Bekci, R. Demir, N. Dursunoglu, D. Ediger, A. Ekici, O. Goksel, H. Gunen, I.K. Oguzulgen, Z.F. Ozseker, (Turkey); L. Barnes, T. Hall, S. Montgomerie, J. Purohit, J. Ryan (United Kingdom). The authors would also like to thank P. Galletti (THERAMetrics S.p.A., Sesto San Giovanni, Italy) and K. Stockmeyer (THERAMetrics GmbH, Essen, Germany) for providing editorial assistance in the preparation of this manuscript.Peer reviewedPublisher PD

Determinants and impact of suboptimal anthma control in Europe: the international cross-sectional and longitudinal assessment on asthma control (Liaison study)

Background: according to the Global Initiative of Asthma, the aim of asthma treatment is to gain and maintain control. In the INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study, we evaluated the level of asthma control and quality of life (QoL), as well as their determinants and impact in a population consulting specialist settings. Methods: LIAISON is a prospective, multicentre, observational study with a cross-sectional and a 12-month longitudinal phase. Adults with an asthma diagnosis since at least 6 months, receiving the same asthma treatment in the 4 weeks before enrolment were included. Asthma control was assessed with the 6-item Asthma Control Questionnaire (ACQ) and QoL with the MiniAsthma Quality of Life Questionnaire (MiniAQLQ). Results: overall, 8111 asthmatic patients were enrolled in 12 European countries. Asthma control was suboptimal in 56.5 % of patients and it was associated with poorer asthma-related QoL, higher risk of exacerbations and greater consumption of healthcare resources. Variables associated with suboptimal control were age, gender, obesity, smoking and comorbidities. Major determinants of poor asthma control were seasonal worsening and persisting exposure to allergens/irritants/triggers, followed by treatment-related issues. Conclusions: the cross-sectional phase results confirm that suboptimal control is frequent and has a high individual and economic impact. Trial registration: The clinicaltrials.gov identifier is NCT01567280

Exploring Quality of Life and Satisfaction with Treatment in Asthmatic Patients Receiving Dry Powder Inhalers: A Multinational Survey

Introduction: The quality of life (QoL) and device needs have not been characterized in asthmatic patients treated via dry powder inhalers (DPIs). The aim of this study was to assess the impact of asthma on health-related QoL, device satisfaction and preference in adult asthmatic patients using DPI devices, and to identify any DPI-associated unmet needs.Methods: An online survey was conducted between November and December 2019 on eligible patients from the Cint consumer panel across Europe. Newly designed, as well as validated questionnaires were used to collect data on QoL and inhaler satisfaction.Results: A total of 1063 asthmatic patient took part in the survey; 66% of the patients reported medium or high impact of asthma on the overall QoL. The majority of patients (61%) reported high level of satisfaction with their current device. The patients with medium-to-high impact of asthma on QoL were significantly less likely to be satisfied with their current device (55%) than those who reported low-to-medium impact of asthma on QoL (67%; p-value <0.001). "Higher number of available doses', 'usability', 'clear dose counter" and 'feedback on correct inhalation' were the attributes mostly requested from a new device. The demand for user-friendly devices that provide feedback on correct drug administration was identified as an unmet need.Conclusions & Clinical Relevance: In asthmatic patients with medium to high impact of asthma on the overall QoL, the satisfaction with the device is highly affected

Single and multiple ascending dose studies of a novel tissue-selective oestrogen receptor modulator, CHF 4227, in healthy postmenopausal women

What is already known about this subjec

Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD

BACKGROUND: The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate (BDP/FF) extrafine combination versus fluticasone propionate/salmeterol (FP/S) combination in COPD patients. METHODS: The trial was a 12-week multicentre, randomised, double-blind, double dummy study; 419 patients with moderate/severe COPD were randomised to BDP/FF 200/12 μg or FP/S 500/50 μg twice daily. The primary objective was to demonstrate the equivalence between treatments in terms of Transition Dyspnoea Index (TDI) score and the superiority of BDP/FF in terms of change from pre-dose in the first 30 minutes in forced expiratory volume in the first second (FEV(1)). Secondary endpoints included lung function, symptom scores, symptom-free days and use of rescue medication, St. George’s Respiratory Questionnaire, six minute walking test and COPD exacerbations. RESULTS: BDP/FF was equivalent to FP/S in terms of TDI score and superior in terms of FEV(1) change from pre-dose (p < 0.001). There were no significant differences between treatments in secondary outcome measures, confirming overall comparability in terms of efficacy and tolerability. Moreover, a clinically relevant improvement (>4 units) in SGRQ was detected in the BDP/FF group only. CONCLUSION: BDP/FF extrafine combination provides COPD patients with an equivalent improvement of dyspnoea and a faster bronchodilation in comparison to FP/S. TRIAL REGISTRATION: ClinicalTrials.gov: NCT0124556