Design of a Study Assessing Disease Behaviour During the Peri-Diagnostic Period in Patients with Interstitial Lung Disease: The STARLINER Study

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  • Marlies Wijsenbeek, Erasmus MC, Erasmus University Rotterdam, Erasmus University Medical Center, Univ Med Ctr Rotterdam, Dept Neurol
  • ,
  • Elisabeth Bendstrup
  • Claudia Valenzuela, Hosp Univ La Princesa, Hospital de La Princesa, Inst Invest Princesa
  • ,
  • Michael T. Henry, Cork Univ Hosp, University College Cork
  • ,
  • Catharina Moor, Erasmus MC, Erasmus University Rotterdam, Erasmus University Medical Center, Univ Med Ctr Rotterdam, Dept Neurol
  • ,
  • Monica Bengus, F Hoffmann La Roche Ltd, Roche Holding
  • ,
  • Andras Perjesi, F Hoffmann La Roche Ltd, Roche Holding
  • ,
  • Frank Gilberg, F Hoffmann La Roche Ltd, Roche Holding
  • ,
  • Klaus-Uwe Kirchgaessler, F Hoffmann La Roche Ltd, Roche Holding
  • ,
  • Carlo Vancheri, Univ Catania, University of Catania, Univ Hosp Policlin G Rodolico, Dept Clin & Expt Med, Reg Referral Ctr Rare Lung Dis

Background/ObjectivesThis study will aim to characterise disease behaviour during the peri-diagnostic period in patients with suspected interstitial lung disease (ILD), including idiopathic pulmonary fibrosis (IPF), using daily home spirometry and accelerometry. Additionally, this study will aim to increase collaboration between secondary and tertiary centres using a digital collaboration platform.MethodsThe STARLINER study (NCT03261037) will enrol approximately 180 symptomatic patients aged 50years or more with radiological evidence of ILD/IPF from community and tertiary centres in Canada and Europe. Approximately two-thirds of sites will be community centres. Patients will be followed during pre-diagnosis (inclusion to diagnosis; up to a maximum of 12months) and post-diagnosis (diagnosis to treatment initiation; up to a maximum of 6months). The study will be facilitated by a digital ecosystem consisting of the devices used for home-based assessments and a digital collaboration platform enabling communication between community and tertiary centres, and between clinicians and patients.Planned OutcomesThe primary endpoint will be time-adjusted semi-annual change in forced vital capacity (FVC; in millilitres) during the peri-diagnostic period. Physical functional capacity and patient-reported outcomes (PROs) will also be assessed. FVC and physical functional capacity will be measured using daily home spirometry and accelerometry, and at site visits using spirometry and the 6-min walk test. PROs will be assessed prior to, or during, site visits and will always be completed in the same order.ConclusionsFindings from this study may help to facilitate the early and accurate diagnosis of ILDs by increasing knowledge about disease progression, enabling collaboration between community and tertiary centres and improving communication between clinicians and patients.Trial Registration NumberNCT03261037.FundingF. Hoffmann-La Roche, Ltd., Basel, Switzerland.Plain Language SummaryPlain language summary available for this article.

OriginalsprogEngelsk
TidsskriftAdvances in Therapy
Vol/bind36
Nummer1
Sider (fra-til)232-243
Antal sider12
ISSN0741-238X
DOI
StatusUdgivet - jan. 2019

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