Although it is of great importance for healthcare professionals to ensure that patients’ needs and concerns are valued and that they feel confident in the quality of the care they receive, there have been few studies specifically addressing the opinions, experiences and needs of patients with Bronchiectasis (BE), and more importantly the emotional impact of the disease, diagnosis and treatment.Using enterprise grade social listening tools, a comprehensive search around BE was performed in 5 languages, on different social media platforms between January 2018 and December 2019 to obtain the perspectives of patients and caregivers from 9 countries on symptoms, treatments and burden of the disease.Over 27 000 mentions of BE were identified on social media channels, 38.8% of which were posted by patients and caregivers. Approximately 1600 posts were found on BE symptoms, out of which persistent cough, shortness of breath and mucus production (22%, 20% and 18%, respectively) were the most commonly discussed. The research revealed that existing diagnostic tests often delay diagnosis or provide inaccurate results, leading to multiple rounds of consults and substantial delays in treatment initiation and management of the disease. Misdiagnosis was common across different age groups, especially among patients without severe symptoms and this was associated with an emotional burden of anger, confusion, frustration and anxiety.Analysis of social media presents a new approach to derive insights on patients’ experiences and emotions with BE and has the potential to complement more traditional approaches to drive more patient-focused drug development.

Purpose: A number of single-inhaler, fixed-dose, triple combinations are available for the management of chronic obstructive pulmonary disease and/or asthma. One of these is the extrafine formulation beclomethasone dipropionate, formoterol fumarate, glycopyrronium bromide (BDP/FF/GB). Given that differences in ethnicity can result in differences in systemic exposure, we evaluated the relative pharmacokinetic (PK) profiles of BDP/FF/GB in Japanese vs Caucasian healthy volunteers to assess the need for dose adjustment.Methods: This randomized, double-blind, singledose, 4-way crossover study recruited healthy men and women 20 to 55 years of age; for each Japanese person a Caucasian was enrolled who matched in terms of sex, age, and weight. Study treatments included BDP/FF/GB 200/12/25 and 400/12/25 μg (therapeutic), 800/48/100 μg (supratherapeutic), and placebo. PK blood samples were taken up to 24 hours for evaluation of BDP, beclomethasone 17-monopropionate (B17MP, an active metabolite of BDP), and formoterol and up to 48 h for GB. The primary objective was to characterize the PK profiles of BDP, FF, and GB after administration of a single dose of BDP/FF/GB in Caucasian and Japanese healthy volunteers in terms of the AUC 0-t and C max of B17MP, formoterol, and GB.Findings: Of the 32 recruited participants (16 Japanese and 16 Caucasian ), 30 completed the study. A clear plasma exposure dose-response relationship was found for all 4 molecules. B17MP C max geometric mean ratios for Japanese vs Caucasian participants for the 3 study treatments ranged from 1.17 to 1.26, and AUC 0-t ratios ranged from 1.16 to 1.22; thus, the findings were comparable between the ethnicities. Formoterol exposure was higher in Japanese than Caucasian participants (C max , 1.22-1.53; AUC 0-t , 1.23-1.40). The GB C max with BDP/FF/GB 400/12/25 μg (1.09) and AUC 0-t values for all three doses (0.98-1.17) were comparable in the 2 populations, but C max with 200/12/25 and 800/48/100 μg were higher in Japanese participants (1.32 and 1.42, respectively). Pharmacodynamic (cortisol, potassium, glucose, blood pressure, heart rate, and QT interval with the Fridericia correction) and safety profile results were similar in the 2 ethnicities, with most patients not experiencing any adverse events.Implications: Exposure to BDP/FF/GB pressurized metered dose inhaler at therapeutic and supratherapeutic doses was associated with higher plasma levels in Japanese versus Caucasian healthy volunteers. These PK differences did not translate into meaningful dif-

IntroductionExercise induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young adults. Current management generally consists of breathing advice, speech therapy, inspiratory muscle training (IMT), or supraglottoplasty in highly motivated subjects with supraglottic collapse. Inhaled ipratropium bromide (IB) is a muscarinic-receptor antagonist used to treat asthma, and suggested in a few reports to improve EILO symptoms.AimTo investigate effects of inhaled IB in EILO diagnosed by continuous laryngoscopy exercise (CLE) test and classified by CLE-scores.MethodsA randomized crossover trial, conducted at Haukeland University Hospital, Bergen, Norway, enrolling participants diagnosed with EILO defined by characteristic symptoms and CLE-score≥3 (range 0–12). Two consecutive CLE-tests were performed within two weeks, one test with and one test without prior administration of inhaled IB in a randomized order. Main outcomes were the CLE-score, dyspnoea measured using a modified BORG scale (range 0–10) and cardiopulmonary exercise data provided by the CLE-test.ResultsTwenty participants (14 females) aged 12–25 years participated, and all ran to exhaustion on both tests. Mean CLE-score, Borg score, and peak oxygen consumption were similar in tests performed with and without IB, mean differences (95% confidence interval) were 0.08 (−0.28 to 0.43), 0.35 (−0.29 to 0.99), and −0.4 (−1.9 to 1.1) ml−1kg·min−1, respectively.ConclusionInhaled IB did not improve CLE-score, dyspnoea, or exercise capacity in subjects with EILO. The study does not support the use of inhaled IB to treat EILO.

The prevalence of asthma in Japan has been increasing and a substantial proportion of patients continue to suffer from uncontrolled asthma. BDP/FF/GB pMDI is a single-inhaler ICS/LABA/LAMA triple therapy developed for the maintenance treatment of patients with asthma not adequately controlled on medium-to-high doses ICS/LABA. Since responses to pharmacological therapy can be affected by race and ethnicity, we investigated the pharmacokinetics (PK) and pharmacodynamics (PD) of BDP/FF/GB pMDI in healthy Japanese subjects in comparison to their Caucasian counterparts. METHODS: In this single-centre, randomised, double-blind, single dose, 4-way cross-over, placebo-controlled ethnic sensitivity study, healthy Japanese and Caucasian subjects received two different therapeutic doses (TD) of BDP/FF/GB, namely TD1 (200/ 12/25 mg) and TD2 (400/12/25 mg) and a supratherapeutic dose (STD, 800/48/100 mg), as well as a matching placebo separated by 21-day washout periods. Serial PK and PD assessments were conducted pre-dose and up to 48 hours post-dose. Vital signs, electrocardiograms (ECG) and treatment-emergent adverse events (TEAEs) were also monitored for the assessment of safety. Ethnic comparability was assessed by descriptive statistics.

Background and Aims Apolipoprotein L1 (APOL1) toxic gain-of-function variants (G1 or G2) are genetic factors driving a broad spectrum of progressive, proteinuric nephropathies referred to as APOL1-mediated kidney disease (AMKD). APOL1 genotyping is not routinely performed in kidney disease care, and prevalence of APOL1 variants among persons with chronic kidney disease (CKD) in Europe is not well known. These variants are common in persons of recent African ancestry. We report interim data of a global study estimating the prevalence of APOL1 genotypes in participants of recent African ancestry and proteinuric CKD, with a focus on data from Europe. Method Enrollment in this ongoing study will include up to 2,500 participants across different geographies who are of recent African ancestry and have focal segmental glomerulosclerosis (FSGS) or other proteinuric nondiabetic kidney disease (NDKD). The study includes a single visit during which blood samples are collected from participants to determine their APOL1 genotype using a validated polymerase chain reaction (PCR)-based assay. The percent of participants with two APOL1 variants and percent of participants in each genotype category (e.g., G1/G1, G1/G2, G2/G2) are assessed; genetic counseling services are available to participants, if desired. Results This interim analysis included 1,256 participants of whom 174 (13.9%) were from Europe. As shown in the table, among the 88 participants with FSGS and 86 participants with proteinuric NDKD, 54 (61.4%) and 32 (37.2%) have two APOL1 variants, respectively. Conclusion Our study will generate one of the largest global APOL1 genotyping data sets in participants with proteinuric kidney disease. These data begin to address a critical knowledge gap and highlight the importance of APOL1 genotyping in kidney disease care to identify AMKD, potentially optimize disease management, and enable referral for interventional clinical trials evaluating targeted therapies for AMKD.