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• W3206806532 abstract "TOPIC: Diffuse Lung Disease TYPE: Original Investigations PURPOSE: In idiopathic pulmonary fibrosis (IPF) clinical trials, change in forced vital capacity (FVC) is commonly the primary endpoint; however, the method of FVC measurement can vary between trials, with some protocols requiring standardized spirometry equipment to be used across all centers, with central reading, and some protocols allowing for centers to use their own spirometry equipment, with local reading. This pooled exploratory analysis compared visit-to-visit variability in FVC (mL and percent change) measured prior to bronchodilation between central reads (standardized equipment) and local reads (non-standardized equipment). METHODS: Patients with IPF were included from four randomized controlled trials. Local reads were analyzed for patients from the placebo arms of the CAPACITY studies (NCT00287716; NCT00287729), in which each site used its own spirometry equipment. Central reads using standardized equipment were analyzed for patients from the placebo arm of ASCEND (NCT01366209), and all patients in RIFF (Cohort A; NCT01872689); in the latter, no treatment effect was detected in the lebrikizumab arm. In this analysis, absolute change (mL), its corresponding coefficient of variation (CV), and percent change (% change) in FVC over 3-month intervals were investigated. RESULTS: Local reads were obtained from 347 patients (1857 observations) and central reads from 431 patients (1504 observations). Overall, 78.5% of local and 82.4% of central reads showed an FVC change within the range of –200 mL to <200 mL, while 88.5% of local and 88.8% of central reads showed an FVC change within the range of –10% to <10%. The frequency distributions of FVC change (mL and % change) indicated that increases in FVC were slightly more common with local reads, while decreases were slightly more common with central reads, although the observed differences were minor. The CV of absolute change in FVC was <5% for 195/341 (57.2%) locally and 231/413 (55.9%) centrally read patients; the Ogive plots of CV appeared similar for local and central reads and the cumulative distributions did not differ significantly on a Kolmogorov-Smirnov two-sample test. CONCLUSIONS: The visit-to-visit variability in local vs central reads of FVC (mL) absolute change from baseline over 3-month intervals showed no statistical difference in individual patient CV. Local reads may be more likely to identify improvements in FVC and central reads may be more likely to identify worsening in FVC over 3-month intervals, although the observed differences were not clinically meaningful. CLINICAL IMPLICATIONS: This analysis is limited by the lack of a head-to-head comparison between local and central reads in the same population, and different equipment in the two studies that employed central reads. Therefore, interpretation should be made cautiously and the findings do not indicate whether central or local spirometry should be used in IPF clinical trials. DISCLOSURES: No relevant relationships by Tilley Jewell, source=Web Response Advisory Committee Member relationship with Boehringer-Ingelheim Please note: current Added 04/23/2021 by Kerri Johannson, source=Web Response, value=Honoraria Consultant relationship with Hoffman La Roche Please note: current Added 04/23/2021 by Kerri Johannson, source=Web Response, value=Honoraria Consultant relationship with Theravance Please note: $1001 - $5000 by Kerri Johannson, source=Web Response, value=Consulting fee Removed 04/22/2021 by Kerri Johannson, source=Web Response Advisory Committee Member relationship with Blade Therapeutics Please note: $1001 - $5000 by Kerri Johannson, source=Web Response, value=Honoraria Removed 04/22/2021 by Kerri Johannson, source=Web Response Grant relationship with Chest Foundation Please note: $20001 - $100000 by Kerri Johannson, source=Web Response, value=Grant/Research Removed 04/22/2021 by Kerri Johannson, source=Web Response Grant relationship with Chest Foundation Please note: completed 2020 Added 04/23/2021 by Kerri Johannson, source=Web Response, value=Grant/Research Grant relationship with UCB Biopharma Please note: $20001 - $100000 by Kerri Johannson, source=Web Response, value=Grant/Research Support Removed 04/22/2021 by Kerri Johannson, source=Web Response Consultant relationship with Three Lakes Foundation Please note: current Added 04/23/2021 by Kerri Johannson, source=Web Response, value=Consulting fee Consultant relationship with Boehringer Ingelheim Please note: current Added 04/23/2021 by Kerri Johannson, source=Web Response, value=Consulting fee Consultant relationship with Pliant Therapeutics Please note: Current Added 04/22/2021 by Kerri Johannson, source=Web Response, value=Consulting fee No relevant relationships by Deidre Kile, source=Web Response Employee relationship with F. Hoffmann - La Roche Ltd. Please note: 2015-2021 Added 04/23/2021 by Klaus-Uwe Kirchgaessler, source=Web Response, value=Salary Shareholder relationship with F. Hoffmann - La Roche Ltd. Please note: 2015-2021 Added 04/23/2021 by Klaus-Uwe Kirchgaessler, source=Web Response, value=Dividends Consultant relationship with Boehringer Ingelheim Please note: 2020 - 2021 Added 04/27/2021 by Toby Maher, source=Web Response, value=Consulting fee Consultant relationship with Genentech Please note: 2020 - 2021 Added 04/27/2021 by Toby Maher, source=Web Response, value=Consulting fee Consultant relationship with Galapagos Please note: 2020 - 2021 Added 04/27/2021 by Toby Maher, source=Web Response, value=Consulting fee Consultant relationship with Astra Zeneca Please note: 2020 - 2021 Added 04/27/2021 by Toby Maher, source=Web Response, value=Consulting fee Consultant relationship with BMS Please note: 2020 - 2021 Added 04/27/2021 by Toby Maher, source=Web Response, value=Consulting fee Employee relationship with Roche Please note: >$100000 by John Stauffer, source=Web Response, value=Stock Removed 04/22/2021 by John Stauffer, source=Web Response Stock holder relationship with Roche, Inc. Please note: 2015 - present Added 04/22/2021 by John Stauffer, source=Web Response, value=Stock Employee relationship with Genentech, Inc. Please note: 2015 - present Added 04/22/2021 by John Stauffer, source=Web Response, value=Salary" @default.
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• W3206806532 date "2021-10-01" @default.
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• W3206806532 title "VARIABILITY IN CENTRAL AND LOCAL MEASUREMENT OF FVC IN IDIOPATHIC PULMONARY FIBROSIS: AN EXPLORATORY ANALYSIS FROM THE CAPACITY, ASCEND, AND RIFF (COHORT A) TRIALS" @default.
• W3206806532 doi "https://doi.org/10.1016/j.chest.2021.07.1147" @default.
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