NCT04961060|Unknown
Drivers of Eosinophilic COPD Exacerbations
DICE
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DICE
Sponsor study identifier
observational
100
1 country
2
Study Start
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Main objective: investigate gene expression differences in nasal epithelium and sputum between eosinophilic COPD exacerbations and other subtypes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 28, 2021
Actual (reported)July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 14, 2021
Actual (reported)September 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in gene expression profiles in sputum by RNA sequencing
Change in gene expression profiles in sputum between the four groups using RNA sequencing. The differences between the expression levels of transcripts (counts) will be analyzed.
At admission and after 6-8 weeks after discharge.
Change in gene expression profiles in nasal epithelium by using RNA sequencing
Change in gene expression profilesin nasal epithelium between the four groups using RNA sequencing. The differences between the expression levels of transcripts (counts) will be analyzed.
At admission and after 6-8 weeks after discharge.
Microbiome composition in sputum by using RNA sequencing.
At admission, at day 5 of admission and 6-8 weeks after discharge.
Phenotype blood cell population by flow cytometry.
At admission, at day 5 of admission and 6-8 weeks after discharge.
Phenotypic analysis of the T cell compartment by staining of whole blood or isolated peripheral blood mononuclear cells using antibodies
At admission, at day 5 of admission and 6-8 weeks after discharge.
Comparison of microbiome composition in sputum and nasal epithelial material by RNA sequencing.
At admission and 6-8 weeks after discharge.
Clinical differences between groups by the COPD Assessment Test (CAT).
Every day of hospital admission.
COPD exacerbation associated with eosinophilia.
COPD exacerbation associated with viral infection.
COPD exacerbation associated bacterial infection.
Pauci-inflammatory COPD exacerbation
Patients admitted to the UMCG or MUMC for a COPD exacerbation.
University Maastricht
Maastricht, Limburg, 6229 GT, Netherlands
Univesity Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Wang Z, Singh R, Miller BE, Tal-Singer R, Van Horn S, Tomsho L, Mackay A, Allinson JP, Webb AJ, Brookes AJ, George LM, Barker B, Kolsum U, Donnelly LE, Belchamber K, Barnes PJ, Singh D, Brightling CE, Donaldson GC, Wedzicha JA, Brown JR; COPDMAP. Sputum microbiome temporal variability and dysbiosis in chronic obstructive pulmonary disease exacerbations: an analysis of the COPDMAP study. Thorax. 2018 Apr;73(4):331-338. doi: 10.1136/thoraxjnl-2017-210741. Epub 2017 Dec 21.
Bafadhel M, McKenna S, Terry S, Mistry V, Reid C, Haldar P, McCormick M, Haldar K, Kebadze T, Duvoix A, Lindblad K, Patel H, Rugman P, Dodson P, Jenkins M, Saunders M, Newbold P, Green RH, Venge P, Lomas DA, Barer MR, Johnston SL, Pavord ID, Brightling CE. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med. 2011 Sep 15;184(6):662-71. doi: 10.1164/rccm.201104-0597OC.
Blood
Maarten van den Berge, PhD
University Medical Center Groningen
First Submitted
April 28, 2021
First Posted
July 14, 2021
Study Start
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2024
The Effect of Incentive Spirometry Added to Routine Physiotherapy Program on Hemodynamic Responses and Hospital Stay in Patients With COPD Exacerbation
Contact the study team to confirm eligibility.
Mayhew D, Devos N, Lambert C, Brown JR, Clarke SC, Kim VL, Magid-Slav M, Miller BE, Ostridge KK, Patel R, Sathe G, Simola DF, Staples KJ, Sung R, Tal-Singer R, Tuck AC, Van Horn S, Weynants V, Williams NP, Devaster JM, Wilkinson TMA; AERIS Study Group. Longitudinal profiling of the lung microbiome in the AERIS study demonstrates repeatability of bacterial and eosinophilic COPD exacerbations. Thorax. 2018 May;73(5):422-430. doi: 10.1136/thoraxjnl-2017-210408. Epub 2018 Jan 31.
Imkamp K, Berg M, Vermeulen CJ, Heijink IH, Guryev V, Kerstjens HAM, Koppelman GH, van den Berge M, Faiz A. Nasal epithelium as a proxy for bronchial epithelium for smoking-induced gene expression and expression Quantitative Trait Loci. J Allergy Clin Immunol. 2018 Jul;142(1):314-317.e15. doi: 10.1016/j.jaci.2018.01.047. Epub 2018 Mar 6. No abstract available.
Boudewijn IM, Lan A, Faiz A, Cox CA, Brouwer S, Schokker S, Vroegop SJ, Nawijn MC, Woodruff PG, Christenson SA, Hagedoorn P, Frijlink HW, Choy DF, Brouwer U, Wisman M, Postma DS, Fingleton J, Beasley R, van den Berge M, Guryev V. Nasal gene expression changes with inhaled corticosteroid treatment in asthma. Allergy. 2020 Jan;75(1):191-194. doi: 10.1111/all.13952. Epub 2019 Jul 15. No abstract available.
Liesker JJ, Bathoorn E, Postma DS, Vonk JM, Timens W, Kerstjens HA. Sputum inflammation predicts exacerbations after cessation of inhaled corticosteroids in COPD. Respir Med. 2011 Dec;105(12):1853-60. doi: 10.1016/j.rmed.2011.07.002. Epub 2011 Jul 29.
Caramori G, Casolari P, Barczyk A, Durham AL, Di Stefano A, Adcock I. COPD immunopathology. Semin Immunopathol. 2016 Jul;38(4):497-515. doi: 10.1007/s00281-016-0561-5. Epub 2016 May 13.
Brusselle GG, Joos GF, Bracke KR. New insights into the immunology of chronic obstructive pulmonary disease. Lancet. 2011 Sep 10;378(9795):1015-26. doi: 10.1016/S0140-6736(11)60988-4.
Zhu J, Paul WE. Peripheral CD4+ T-cell differentiation regulated by networks of cytokines and transcription factors. Immunol Rev. 2010 Nov;238(1):247-62. doi: 10.1111/j.1600-065X.2010.00951.x.
Travers J, Rothenberg ME. Eosinophils in mucosal immune responses. Mucosal Immunol. 2015 May;8(3):464-75. doi: 10.1038/mi.2015.2. Epub 2015 Mar 25.
Aguirre-Gamboa R, Joosten I, Urbano PCM, van der Molen RG, van Rijssen E, van Cranenbroek B, Oosting M, Smeekens S, Jaeger M, Zorro M, Withoff S, van Herwaarden AE, Sweep FCGJ, Netea RT, Swertz MA, Franke L, Xavier RJ, Joosten LAB, Netea MG, Wijmenga C, Kumar V, Li Y, Koenen HJPM. Differential Effects of Environmental and Genetic Factors on T and B Cell Immune Traits. Cell Rep. 2016 Nov 22;17(9):2474-2487. doi: 10.1016/j.celrep.2016.10.053. Epub 2016 Nov 3.
Narendra DK, Hanania NA. Targeting IL-5 in COPD. Int J Chron Obstruct Pulmon Dis. 2019 May 16;14:1045-1051. doi: 10.2147/COPD.S155306. eCollection 2019.
Ditz B, Christenson S, Rossen J, Brightling C, Kerstjens HAM, van den Berge M, Faiz A. Sputum microbiome profiling in COPD: beyond singular pathogen detection. Thorax. 2020 Apr;75(4):338-344. doi: 10.1136/thoraxjnl-2019-214168. Epub 2020 Jan 29.
Gao P, Gibson PG, Zhang J, He X, Hao Y, Li P, Liu H. The safety of sputum induction in adults with acute exacerbation of COPD. Clin Respir J. 2013 Jan;7(1):101-9. doi: 10.1111/j.1752-699X.2012.00291.x. Epub 2012 Apr 23.
Pavord ID, Chanez P, Criner GJ, Kerstjens HAM, Korn S, Lugogo N, Martinot JB, Sagara H, Albers FC, Bradford ES, Harris SS, Mayer B, Rubin DB, Yancey SW, Sciurba FC. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017 Oct 26;377(17):1613-1629. doi: 10.1056/NEJMoa1708208. Epub 2017 Sep 11.
Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramirez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.
Bi R, Liu P. Sample size calculation while controlling false discovery rate for differential expression analysis with RNA-sequencing experiments. BMC Bioinformatics. 2016 Mar 31;17:146. doi: 10.1186/s12859-016-0994-9.
Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
Celli BR, Locantore N, Tal-Singer R, Riley J, Miller B, Vestbo J, Yates JC, Silverman EK, Owen CA, Divo M, Pinto-Plata V, Wouters EFM, Faner R, Agusti A; ECLIPSE Study Investigators. Emphysema and extrapulmonary tissue loss in COPD: a multi-organ loss of tissue phenotype. Eur Respir J. 2018 Feb 7;51(2):1702146. doi: 10.1183/13993003.02146-2017. Print 2018 Feb.
van Krimpen SJ, Koenen HJPM, van Cranenbroek B, van Rijssen E, van Smoorenburg LH, Staats-Niemeijer A, de Wit NCJ, Verweij JJ, Franssen FME, Gosker HR, Langen RCJ, Schols AMWJ, Kerstjens HAM, van den Berge M, de Jonge MI, Simons SO. Hemocytometric Parameters Associated with Bacterial and Viral Etiology in COPD Exacerbations: An Exploratory Analysis. COPD. 2026 Dec;23(1):2733469. doi: 10.1080/15412555.2026.2733469. Epub 2026 Oct 14.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 14, 2021
Record last verified: 2021-07
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