Background The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudorandom number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178.
TakedownIf you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing firstname.lastname@example.org including the URL of the record and the reason for the withdrawal request. Abstract: Soundscape research represents a paradigm shift from noise control policies towards a new multidisciplinary approach as it involves not only physical measurements but also the cooperation of humanity and social sciences to account for the diversity of soundscapes across countries and cultures, with more focus on how people actually experience the acoustic environments; and it considers environmental sounds as a 'resource' rather than a 'waste'. The ten questions presented in this paper range from the very basic definitions underlying the emerging soundscape 'science', to more applied topics about how to use soundscape as a design approach for the planning and management of the built environments. Although significant research activity has been conducted so far, there is still a need to systematically provide the underpinning science and practical guidance in soundscaping. Thus, the last question aims to identify the most crucial gaps in soundscape research and set the agenda for future advancements in the field.
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