Clinically Important Improvements and Disease Stability with Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy in the ELLITHE Trial: A Post Hoc Responder Analysis.

Introduction: Responder analyses provide information about characteristics associated with therapeutic benefits. Short-term responses may predict long-term benefits. We evaluated responders, clinically important improvement (CII), disease stability (DS), and the relation of short- to long-term responses in patients with chronic obstructive pulmonary disease (COPD) in ELLITHE.

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.

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.

Cost-Effectiveness of Single-Inhaler Versus Multiple-Inhaler Triple Therapy in COPD: A German Healthcare Perspective.

Purpose: The INTREPID trial showed that once-daily single-inhaler triple therapy (SITT) using fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) offers clinical benefits versus non-ELLIPTA multiple-inhaler triple therapy (MITT) for the management of chronic obstructive pulmonary disease (COPD) in real-world clinical practice. This analysis evaluated the cost-effectiveness of SITT with FF/UMEC/VI versus non-ELLIPTA MITT for treating symptomatic COPD from a German healthcare perspective.

Patients And Methods: Data from the INTREPID trial, including baseline characteristics, treatment effects (forced expiratory volume in 1 second and St.

Unmet needs of patients with COPD in Germany: a retrospective, cross-sectional study.

Background: Earlier diagnosis and treatment of COPD, particularly preventing exacerbations, are key to slowing disease progression and reducing mortality. This study focused on the identification of patients in Germany with unstable COPD due to suboptimal treatments.

Methods: The IQVIA™ LRx database, capturing 80% of Statutory Health Insurance prescriptions was used to identify patients with COPD using a machine-learning model.

How to move towards more sustainable asthma care in Europe: an expert opinion paper.

https://bit.ly/41fQ364.

[Use of long-acting triple therapy for chronic obstructive pulmonary disease (COPD) in practice: The ELETHON physicians' survey].

Gaps in optimal COPD management have been identified in clinical practice, with discrepancies between guideline recommendations and routine care. The reasons for such discrepancies are incompletely understood. The ELETHON survey aimed to identify physicians' attitudes towards general concepts of COPD management and, in particular, initiation of inhaled triple therapies.

Baseline patient demographics for TETRIS: a prospective, noninterventional study to characterize the use of triple therapy for COPD in Germany.

Background: Evidence on how decisions regarding escalation to triple therapy and de- or re-escalation are taken and the rationale on which these decisions are based is currently limited in Germany.

Objectives: The TETRIS study aims to elucidate influences on treatment decisions surrounding triple therapy in a real-world practice setting in Germany.

Design: TETRIS is an ongoing, multicenter, prospective, observational cohort study recruiting patients with chronic obstructive pulmonary disease (COPD) with or without asthma who have already been treated with triple therapy for 2-48 weeks.

Evaluation of Adherence and Persistence to Triple Therapy in Patients with COPD: A German Claims Data Study.

Purpose: Triple therapy (long-acting muscarinic antagonist/long-acting β-agonist/inhaled corticosteroid) is recommended for patients with chronic obstructive pulmonary disease (COPD) who experience recurrent exacerbations. Multiple-inhaler triple therapy (MITT) is associated with poor adherence and persistence. This study assessed comparative adherence and persistence to single-inhaler triple therapy (SITT) versus MITT among patients with COPD in a real-world setting in Germany.

Characteristics of Users and New Initiators of Single- and Multiple-Inhaler Triple Therapy for Chronic Obstructive Pulmonary Disease in Germany.

Purpose: To assess patient characteristics of users and new initiators of triple therapy for chronic obstructive pulmonary disease (COPD) in Germany.

Patients And Methods: Retrospective cohort study of patients with COPD and ≥1 prescription for single-inhaler triple therapy (SITT; fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI] or beclomethasone dipropionate/glycopyrronium bromide/formoterol [BDP/GLY/FOR]) or multiple-inhaler triple therapy (MITT), using data from the AOK PLUS German sickness fund (1 January 2015-31 December 2019). The index date was the first date of prescription for FF/UMEC/VI or BDP/GLY/FOR (SITT users), or the first date of overlap of inhaled corticosteroid, long-acting β-agonist, and long-acting muscarinic antagonist (MITT users).

Real-World Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy for Symptomatic COPD: The ELLITHE Non-Interventional Trial.

Purpose: Real-life effectiveness data on once-daily single-inhaler triple therapy (odSITT) with the inhaled corticosteroid fluticasone furoate (FF), the long-acting muscarinic antagonist umeclidinium (UMEC), and the long-acting β-agonist vilanterol (VI) in patients with chronic obstructive pulmonary disease (COPD) are important to complement evidence from well-controlled randomized clinical trials. Effectiveness of odSITT was quantified by assessing health status and symptoms in usual care.

Patients And Methods: ELLITHE was a single-country (Germany), multicenter, open-label, non-interventional effectiveness study between 2020 and 2022, evaluating the effect of treatment initiation with FF/UMEC/VI 100/62.

Impact of guideline awareness on the counseling of patients with acute cough among general practitioners and pharmacy personnel.

Objective: To explore the awareness and knowledge of applicable guidelines on acute cough among general practitioners, pharmacists and pharmacy technicians and to compare their recommendation behavior and clinical decision making to the evidence-based recommendation in the applicable guidelines.

Methods: An anonymous online survey was performed among 303 members of an existing panel of healthcare professionals (HCPs). They were presented with a hypothetical case vignette representative of their daily practice and asked for their treatment recommendations.

INTREPID: single- multiple-inhaler triple therapy for COPD in usual clinical practice.

Introduction: Real-world trial data comparing single- with multiple-inhaler triple therapy (MITT) in COPD patients are currently lacking. The effectiveness of once-daily single-inhaler fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) and MITT were compared in usual clinical care.

Methods: INTREPID was a multicentre, randomised, open-label, phase IV effectiveness study comparing FF/UMEC/VI 100/62.

Pulmonary Therapy Podcast-COVID-19: Research and Real-World Experiences from the Editorial Board.

The Editorial Board have prepared a podcast describing their experiences over the past year of the COVID-19 pandemic. The Editorial Board describe how COVID-19 impacted their research and how the initial clinical response changed over the course of the year in terms of treatment, personal protective equipment (PPE), and policy changes. The podcast and transcript can be viewed below the abstract of the online version of the manuscript.

Comparison of Dry-Powder Inhaler and Pressurized Metered-Dose Inhaler Formulations of Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium in Patients with COPD: The TRI-D Randomized Controlled Trial.

Background: Three 52-week studies in COPD have assessed the efficacy and safety of single-inhaler extrafine formulation triple therapy combining beclomethasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) delivered via pressurized metered-dose inhaler (pMDI). BDP/FF/G is now being developed for delivery via multi-dose dry-powder inhaler (DPI; NEXThaler). This study aimed to demonstrate non-inferiority of BDP/FF/G DPI vs pMDI for lung function.

COPD patients with chronic bronchitis and higher sputum eosinophil counts show increased type-2 and PDE4 gene expression in sputum.

Chronic obstructive pulmonary disease (COPD) patients with higher eosinophil counts are associated with increased clinical response to phosphodiesterase-4-inhibitors (PDE4i). However, the underlying inflammatory mechanisms associated with this increased response is not yet elucidated. This post hoc analysis focused on sputum gene expression in patients with chronic bronchitis who underwent 32-day treatment with two doses of the inhaled PDE4i CHF6001 (tanimilast) or placebo on top of triple therapy.

COPD sputum eosinophils: relationship to blood eosinophils and the effect of inhaled PDE4 inhibition.

https://bit.ly/3airXw7

Pulmonary Therapy 2020 Update and Podcast: Meet the Journal's Editors-in-Chief.

The Editors-in-Chief of Pulmonary Therapy have prepared podcasts summarizing their current research, recent highlights from the field, and future predictions. Audio-only versions and the transcripts can be downloaded here: https://doi.org/10.

Sputum and blood transcriptomics characterisation of the inhaled PDE4 inhibitor CHF6001 on top of triple therapy in patients with chronic bronchitis.

Background: Although phosphodiesterase-4 (PDE4) inhibitors have been shown to reduce COPD exacerbation rate, their biological mechanism of action is not completely elucidated at the molecular level. We aimed to characterise the whole genome gene expression profile of the inhaled PDE4-inhibitor CHF6001 on top of triple therapy in sputum cells and whole blood of patients with COPD and chronic bronchitis.

Methods: Whole genome gene expression analysis was carried out by microarray in 54 patients before and after 32 days treatment with CHF6001 800 and 1600 μg and placebo twice daily (BID) in a randomised crossover study.

Effect of the inhaled PDE4 inhibitor CHF6001 on biomarkers of inflammation in COPD.

Background: CHF6001 is a novel inhaled phosphodiesterase-4 inhibitor. This Phase IIa study assessed the effects of CHF6001 on markers of inflammation in induced sputum and blood in patients with chronic obstructive pulmonary disease (COPD).

Methods: This was a multicentre, three-period (each 32 days), three-way, placebo-controlled, double-blind, complete-block crossover study.

Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate-to-very-severe COPD: results from a Phase II randomized, double-blind 12-week study.

Background And Purpose: Fixed-dose combinations of a long-acting beta agonist and an inhaled corticosteroid are more effective than the individual components in COPD. The primary study objective was to demonstrate that the combination indacaterol acetate/mometasone furoate (IND/MF [QMF149]) was non-inferior to the twice-daily combination salmeterol xinafoate/fluticasone propionate (Sal/Flu) in terms of trough FEV at week 12 (day 85). Secondary objectives were to compare the efficacy of IND/MF (QMF149) vs Sal/Flu with respect to other lung function parameters, COPD exacerbations, symptoms and dyspnea, health status/health-related quality of life, and rescue medication use.

Characterization of differential patient profiles and therapeutic responses of pharmacy customers for four ambroxol formulations.

Background: Ambroxol relieves cough symptoms based on its secretagogue, anti-inflammatory, anti-oxidant, anti-bacterial, anti-viral, immunomodulatory and local anesthetic effects. The present study was designed to explore differential patient profiles and efficacy against acute respiratory symptoms of four formulations registered as over-the-counter medicines.

Methods: Nine hundred sixty-five pharmacy customers purchasing one of four branded ambroxol formulations (extended release capsules, adult syrup, pediatric syrup and soft pastilles) filled a questionnaire including a patient-adapted version of the Bronchitis Severity Scale, several questions on degree of impairment by acute cough, time to onset of symptom relief and duration of treatment.

Correction to: Long-acting bronchodilators improve exercise capacity in COPD patients: a systematic review and meta-analysis.

In the original publication [1] is an incorrect sentence in the abstract under Conclusions.

Long-acting bronchodilators improve exercise capacity in COPD patients: a systematic review and meta-analysis.

Background: We carried out a systematic review and meta-analysis with the aim to evaluate the efficacy of longacting bronchodilators on exercise capacity in COPD patients.

Methods: The endpoints were the efficacy of long-acting bronchodilators (altogether, and by single classes) vs. placebo in modifying endurance time (ET), inspiratory capacity (IC) and dyspnea during exercise, taking into consideration the outcomes according to different patients’ inclusion criteria and exercise methodology.