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Observational Study
. 2025 Oct:247:108224.
doi: 10.1016/j.rmed.2025.108224. Epub 2025 Jul 9.

Real-world use of beclometasone dipropionate and formoterol fumarate NEXThaler® and asthma control among adult asthmatic patients in Europe: The results of the Newton study

Fulvio Braido  1 , Kai-Michael Beeh  2 , Carolina Cisneros Serrano  3 , Anh Tuan Dinh-Xuan  4 , Lilla Tamási  5 , Antigona Trofor  6 , Eleonora Ingrassia  7 , Alessio Piraino  8 , Cristiano Caruso  9 ; NEWTON study group
Collaborators, Affiliations
Free article
Observational Study

Real-world use of beclometasone dipropionate and formoterol fumarate NEXThaler® and asthma control among adult asthmatic patients in Europe: The results of the Newton study

Fulvio Braido et al. Respir Med. 2025 Oct.
Free article

Abstract

Purpose: The NEWTON study aims to describe clinical characteristics and evolution of asthma control of adult asthmatic patients treated with extrafine beclometasone dipropionate and formoterol fumarate (BDP/FF) NEXThaler® 100/6 μg.

Subjects and methods: NEWTON (NCT05168995) is a European multinational, multicentre, observational, prospective cohort study that included adults with uncontrolled or poorly controlled asthma, starting BDP/FF NEXThaler® 100/6 μg treatment within 14 days of enrolment and with no use of extrafine formulations in the previous 6 months. Improvement of asthma control, lung function, quality of life (QoL), treatment adherence, and satisfaction with the device were assessed after 3 and 6 months from the enrolment visit. In addition, safety events were monitored.

Results: 620 subjects were enrolled in the study. 423 completed the ACQ-5 questionnaire at enrolment and at least once during the following 6 months. 69.3 % of patients were initiated on maintenance and reliever treatment. At baseline, the median ACQ-5 score was 2.0. After 6 months the median ACQ-5 score had decreased significantly to 0.6 (p < 0.0001). Similarly, after 6 months 66.1 % of patients showed improved asthma control. The proportion of subjects with poorly controlled asthma fell from 65.1 % to 17.5 %. These improvements were consistent with the 3-month follow-up results and improved lung function, QoL, treatment adherence and device satisfaction. No new safety concerns were reported.

Conclusion: Results of the NEWTON study confirm the effectiveness and safety of the extrafine fixed combination of BDP/FF NEXThaler® 100/6 μg in adults with uncontrolled asthma in a real-world setting.

Keywords: Asthma; BDP/FF; Extrafine; NEXThaler®; Real-world.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Alessio Piraino reports article publishing charges and writing assistance were provided by Chiesi Italia S.p.A. Fulvio Braido reports financial support was provided by Chiesi Farmaceutici SpA. Carolina Cisneros Serrano reports financial support was provided by Chiesi España SA. Fulvio Braido reports a relationship with GSK that includes: board membership and speaking and lecture fees. Fulvio Braido reports a relationship with Chiesi that includes: board membership and speaking and lecture fees. Fulvio Braido reports a relationship with Menarini group that includes: board membership and speaking and lecture fees. Fulvio Braido reports a relationship with Astra Zeneca that includes: board membership and speaking and lecture fees. Fulvio Braido reports a relationship with Sanofi that includes: board membership and speaking and lecture fees. Fulvio Braido reports a relationship with Regeneron that includes: board membership and speaking and lecture fees. Kai-Michael Beeh reports a relationship with Astra Zeneca that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Kai-Michael Beeh reports a relationship with Chiesi Farmaceutici SpA that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Kai-Michael Beeh reports a relationship with Bosch Healthcare Solutions GmbH that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Kai-Michael Beeh reports a relationship with Berlin-Chemie AG that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Kai-Michael Beeh reports a relationship with Sanofi-Aventis Deutschland GmbH that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Kai-Michael Beeh reports a relationship with GlaxoSmithKline Inc that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Carolina Cisneros Serrano reports a relationship with Sanofi SA that includes: consulting or advisory, funding grants, non-financial support, speaking and lecture fees, and travel reimbursement. Carolina Cisneros Serrano reports a relationship with GlaxoSmithKline SpA that includes: consulting or advisory and speaking and lecture fees. Carolina Cisneros Serrano reports a relationship with AstraZeneca that includes: consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement. Anh Tuan Dinh-Xuan reports a relationship with Boehringer Ingelheim that includes: speaking and lecture fees. Anh Tuan Dinh-Xuan reports a relationship with GSK that includes: speaking and lecture fees. Anh Tuan Dinh-Xuan reports a relationship with Menarini that includes: speaking and lecture fees. Anh Tuan Dinh-Xuan reports a relationship with Sanofi that includes: speaking and lecture fees. Eleonora Ingrassia reports a relationship with Chiesi Italia that includes: employment. Alessio Piraino reports a relationship with Chiesi Farmaceutici SpA that includes: employment. Kai-Michael Beeh declares that, in the past five years, the institution has received compensation for the conduct of clinical trials by the following corporations: AstraZeneca, Bosch Healthcare Solutions GmbH, Chiesi, GSK, Novartis, Sterna. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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