COPD ExacerbationDICENCT04961060
Drivers of Eosinophilic COPD Exacerbations
An observational study of COPD Exacerbation and Eosinophilia, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
Main objective: investigate gene expression differences in nasal epithelium and sputum between eosinophilic COPD exacerbations and other subtypes. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation, Eosinophilia
- How many people
- 100 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jul 2021to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the UMCG or MUMC for a COPD exacerbation.
Who may be able to join
- COPD patient admitted to the hospital for an acute exacerbation of COPD
- Physician diagnosed COPD according to the GOLD 2020 guidelines, including symptoms consistent with COPD, post-bronchodilator FEV1 < 80% predicted and FEV1/FVC < 70%.
- Age > 40 years.
- Smoker or ex-smoker, ≥ 10 pack years of smoking.
Who cannot join
- Current asthma, or prior physician diagnosis of asthma without a symptom- free interval of at least 10 years before the age of 40.
- Chronic use of prednisolone.
- Use of systemic corticosteroids ≥4 days prior to hospital admission.
- Necessity (upon hospitalization) for non-invasive ventilation or ICU admission.
- Pneumonia at presentation documented by chest roentgenography.
- Any other clinically relevant lung disease deemed to interfere with the concept of the study design.
Show all 15Show fewer
- Allergy to systemic corticosteroids or to antibiotics.
- Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
- Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
- Hormonal contraception (implantable, patch, oral, injectable).
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
- Continuous abstinence
- Pregnancy or lactation.
- Known immunodeficiency.
- Life expectancy less than 60 days
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Univesity Medical Center Groningen
Groningen, 9713 GZ
Lisa H van Smoorenburg, MSc., +3150 361 6102, l.h.van.smoorenburg@umcg.nl
Maarten van den Berge, PhD, +3150 361 52 60, m.van.den.berge@umcg.nl
- Not yet recruiting
University Maastricht
Maastricht, Limburg, 6229 GT
Sami O Simons, PhD, +3143 387 55 00, sami.simons@mumc.nl
About this study
Main objective: investigate gene expression differences in nasal epithelium and sputum between eosinophilic COPD exacerbations and other subtypes.
Read the detailed description
Main objective: investigate gene expression differences in nasal epithelium and sputum between eosinophilic COPD exacerbations and other subtypes to better understand why some patients are more at risk for eosinophilic COPD exacerbations. Secondary objectives:
- Investigate differences in microbiome composition and immunophenotyping profiles in peripheral blood per subtype.
- Assess for clinical differences between all COPD exacerbation subtypes.
- Assess if and how baseline meta-transcriptomics either in nasal epithelium or sputum and blood immunophenotyping can be utilized to predict COPD exacerbation subtype.
- Determine if the microbiome in sputum and nasal epithelial material are comparable.
- Determine if different subtypes of COPD exacerbations respond differently to standard treatment with oral prednisolone (40 mg daily) with or without antibiotics.
- To evaluate if metabolic responses during recovery are different in patients with increased systemic inflammation compared to patients without systemic inflammation at exacerbation
- Conditions
- COPD Exacerbation, Eosinophilia
- Medical subject headings
- Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eosinophilic exacerbation | COPD exacerbation associated with eosinophilia. | |
| Viral exacerbation | COPD exacerbation associated with viral infection. | |
| Bacterial exacerbation | COPD exacerbation associated bacterial infection. | |
| Pauci-inflammatory exacerbation | Pauci-inflammatory COPD exacerbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At admission and after 6-8 weeks after discharge.
Secondary outcomes (6)
Microbiome composition in sputum by using RNA sequencing.
Differences in microbiome composition in sputum between the four groups by using RNA sequencing.
Measured: At admission, at day 5 of admission and 6-8 weeks after discharge.
Phenotype blood cell population by flow cytometry.
Differences in blood cell population between the four groups as measured by flow cytometry.
Measured: 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
Differences in the T cell compartment between the four groups by staining of whole blood or isolated peripheral blood mononuclear cells using antibodies.
Measured: 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.
Measure microbiome composition in sputum and nasal epithelium by RNA sequencing. Compare them by the bacterial taxa which are significantly different between groups
Measured: At admission and 6-8 weeks after discharge.
Clinical differences between groups by the COPD Assessment Test (CAT).
Differences in number of participants per group with a high impact of COPD related symptoms as assessed by the CAT.
Measured: Every day of hospital admission.
Clinical differences between groups by peak flow measurements.
Differences in number of participants per group with a low peak expiratory flow rate as measured by a handheld peak flow meter.
Measured: Every day of hospital admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, GlaxoSmithKline
- Responsible party
- Principal investigator, Maarten van den Berge, University Medical Center Groningen
- Investigators
- Maarten van den Berge, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961060
- Sponsor's protocol ID
- NL75151.042.20
- Acronym
- DICE
- Status last verified
- Jul 2021
- First submitted
- 28 Apr 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29269441Bafadhel 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.
PubMed 21680942Mayhew 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.
PubMed 29386298Imkamp 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.
PubMed 29522853Boudewijn 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.
PubMed 31230369Liesker 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.
PubMed 21802933Caramori 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.
PubMed 27178410Brusselle 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.
PubMed 21907865Zhu 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.
PubMed 20969597Travers 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.
PubMed 25807184Aguirre-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.
PubMed 27818087Narendra 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.
PubMed 31190789Ditz 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.
PubMed 31996401Gao 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.
PubMed 22452898Pavord 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.
PubMed 28893134
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drivers of Eosinophilic COPD Exacerbations
- ClinicalTrials.gov ID
- NCT04961060
- Acronym / sponsor ID
- DICE / NL75151.042.20
- Conditions
- COPD Exacerbation, Eosinophilia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Maastricht University, GlaxoSmithKline
- Study start
- Jul 2021 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main objective: investigate gene expression differences in nasal epithelium and sputum between eosinophilic COPD exacerbations and other subtypes.
Detailed description
Main objective: investigate gene expression differences in nasal epithelium and sputum between eosinophilic COPD exacerbations and other subtypes to better understand why some patients are more at risk for eosinophilic COPD exacerbations. Secondary objectives:
- Investigate differences in microbiome composition and immunophenotyping profiles in peripheral blood per subtype.
- Assess for clinical differences between all COPD exacerbation subtypes.
- Assess if and how baseline meta-transcriptomics either in nasal epithelium or sputum and blood immunophenotyping can be utilized to predict COPD exacerbation subtype.
- Determine if the microbiome in sputum and nasal epithelial material are comparable.
- Determine if different subtypes of COPD exacerbations respond differently to standard treatment with oral prednisolone (40 mg daily) with or without antibiotics.
- To evaluate if metabolic responses during recovery are different in patients with increased systemic inflammation compared to patients without systemic inflammation at exacerbation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eosinophilic exacerbation | – | –COPD exacerbation associated with eosinophilia. |
| Viral exacerbation | – | –COPD exacerbation associated with viral infection. |
| Bacterial exacerbation | – | –COPD exacerbation associated bacterial infection. |
| Pauci-inflammatory exacerbation | – | –Pauci-inflammatory COPD exacerbation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the UMCG or MUMC for a COPD exacerbation.
Key inclusion criteria (4 listed)
- COPD patient admitted to the hospital for an acute exacerbation of COPD
- Physician diagnosed COPD according to the GOLD 2020 guidelines, including symptoms consistent with COPD, post-bronchodilator FEV1 < 80% predicted and FEV1/FVC < 70%.
- Age > 40 years.
- Smoker or ex-smoker, ≥ 10 pack years of smoking.
Key exclusion criteria (15 listed)
- Current asthma, or prior physician diagnosis of asthma without a symptom- free interval of at least 10 years before the age of 40.
- Chronic use of prednisolone.
- Use of systemic corticosteroids ≥4 days prior to hospital admission.
- Necessity (upon hospitalization) for non-invasive ventilation or ICU admission.
- Pneumonia at presentation documented by chest roentgenography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in gene expression profiles in sputum by RNA sequencing
Time frame: At admission and after 6-8 weeks after discharge.
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.
Change in gene expression profiles in nasal epithelium by using RNA sequencing
Time frame: At admission and after 6-8 weeks after discharge.
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.
6 secondary outcomes
Microbiome composition in sputum by using RNA sequencing.
Time frame: At admission, at day 5 of admission and 6-8 weeks after discharge.
Phenotype blood cell population by flow cytometry.
Time frame: 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
Time frame: 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.
Time frame: At admission and 6-8 weeks after discharge.
Clinical differences between groups by the COPD Assessment Test (CAT).
Time frame: Every day of hospital admission.
Clinical differences between groups by peak flow measurements.
Time frame: Every day of hospital admission.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Background: PubMed 29269441Wang 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.
- Background: PubMed 21680942Bafadhel 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.
- Background: PubMed 29386298Mayhew 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.
- Background: PubMed 29522853Imkamp 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.
- Background: PubMed 31230369Boudewijn 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.
- Background: PubMed 21802933Liesker 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.
- Background: PubMed 27178410Caramori 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.
- Background: PubMed 21907865Brusselle 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.
- Background: PubMed 20969597Zhu 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.
- Background: PubMed 25807184Travers 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.
- Background: PubMed 27818087Aguirre-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.
- Background: PubMed 31190789Narendra 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten van den Berge, PhD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation and Eosinophilia, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa H van Smoorenburg, MSc. (+3150 361 6102, l.h.van.smoorenburg@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gene expression profiles in sputum by RNA sequencing (time frame: At admission and after 6-8 weeks after discharge.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961060, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.