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Background Digital biomarkers are a promising novel method to capture clinical data in a home setting. However, clinical validation prior to implementation is of vital importance. The aim of this study was to clinically validate physical activity, heart rate, sleep and forced expiratory volume in 1 s (FEV 1 ) as digital biomarkers measured by a smartwatch and portable spirometer in children with asthma and cystic fibrosis (CF). Methods This was a prospective cohort study including 60 children with asthma and 30 children with CF (aged 6–16 years). Participants wore a smartwatch, performed daily spirometry at home and completed a daily symptom questionnaire for 28 days. Physical activity, heart rate, sleep and FEV 1 were considered candidate digital end-points. Data from 128 healthy children were used for comparison. Reported outcomes were compliance, differenc...

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Background The purinoceptor subtype P2X 3 has been shown to have significant involvement in the cough reflex; the heterotrimer version of the purinoceptor (P2X 2/3 ) has been implicated in taste disturbance. The most advanced clinical candidate antagonist gefapixant has low selectivity among P2X 3 receptors and induced taste disturbance, whereas newly developed sivopixant has high selectivity towards P2X 3 versus P2X 2/3 . Methods In a phase 2a, randomised, double-blind, placebo-controlled, crossover, multicentre study, adult patients with refractory or unexplained chronic cough received oral sivopixant 150 mg or placebo once daily for 2 weeks, followed by a 2–3-week washout period, and then crossed over to placebo or sivopixant for 2 weeks. Efficacy and safety of sivopixant were evaluated. Results Of 31 randomised patients, 15 in the sivopixant-first...

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In the pathogenesis of asthma in children there is a pivotal role for a type 2 inflammatory response to early life exposures or events. Interactions between infections, atopy, genetic susceptibility and environmental exposures (such as farmyard environment, air pollution and tobacco smoke exposure) influence the development of wheezing illness and the risk of progression to asthma. The immune system, lung function and the microbiome in gut and airways develop in parallel, and dysbiosis of the microbiome may be a critical factor in asthma development. Increased infant weight gain and preterm birth are other risk factors for development of asthma and reduced lung function. The complex interplay between these factors explains the heterogeneity of asthma in children. Subgroups of patients can be identified as phenotypes, based on clinical parameters, or endotypes, based on a specific pathop...

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The fraction of exhaled nitric oxide ( F ENO ) is a biomarker for type 2 asthma, reflecting the degree of local pulmonary inflammation linked to immune pathways, including interleukin (IL)-13 [1]. In clinical practice, F ENO is a reliable marker for inhaled corticosteroid (ICS) responsiveness [2] and the efficacy of biological therapies, such as those targeting IL-4/IL-13 pathways [3, 4], as well as the detection of steroid nonadherence or resistance in severe asthma [2]. The prospective Severe Asthma Registry of the German Asthma Net (GAN) enrols patients with severe asthma for in-depth assessment of phenotypes, underlying mechanisms and therapeutic strategies; GAN has been approved by respective ethics committees, with all included patients having signed informed consent [5]. Prior studies of F ENO either included patients with asthma of any severity [6] or did not involve a co...

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Objectives Lumacaftor–ivacaftor is a cystic fibrosis transmembrane conductance regulator (CFTR) modulator known to improve clinical status in people with cystic fibrosis (CF). The aim of this study was to assess lung structural changes after 1 year of lumacaftor–ivacaftor treatment and to use unsupervised machine learning to identify morphological phenotypes of lung disease that are associated with response to lumacaftor–ivacaftor. Methods Adolescents and adults with CF from a French multicentre real-world prospective observational study evaluating the first year of treatment with lumacaftor–ivacaftor were included if they had pre-therapeutic and follow-up chest computed tomography (CT) scans available. CT scans were visually scored using a modified Bhalla score. A k-means clustering method was performed based on 120 radiomics features extracted from u...

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Background Proposed criteria for progressive fibrosing interstitial lung disease (PF-ILD) have been linked to increased mortality risk, but lung function trajectory after satisfying individual criteria remains unknown. Because survival is rarely employed as the primary end-point in therapeutic trials, identifying PF-ILD criteria that best predict subsequent change in forced vital capacity (FVC) could improve clinical trial design. Methods A retrospective, multicentre longitudinal cohort analysis was performed in consecutive patients with fibrotic connective tissue disease-associated ILD (CTD-ILD), chronic hypersensitivity pneumonitis and idiopathic interstitial pneumonia at three US centres (test cohort) and one UK centre (validation cohort). 1-year change in FVC after satisfying proposed PF-ILD criteria was estimated using joint modelling. Subgroup analyses were performed to dete...

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"Respiratory" Product Sub-categories