Pulmonary Disease, Chronic ObstructiveECLIPSENCT00292552
Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 44 sites in 12 countries.
Trial summary
This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Novel endpoint determination
- Type of treatment
- Injection or infusion
- How many people
- 2,747 participants
- Where
- 44 sitesin 12 countries
- Study dates
- Dec 2005to Feb 2010
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD subjects and smoking and non-smoking controls
Who may be able to join
- COPD Subjects
- A COPD subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female subjects, aged 40-75 years inclusive
- A baseline (post-bronchodilator) FEV1 <80% of predicted normal and a baseline (post-bronchodilator) FEV1/FVC ratio 70%
- Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack years = (number of cigarettes per day / 20) x number of years smoked e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
- A signed and dated written informed consent is obtained prior to participation
Show all 21Show fewer
- Able to comply with the requirements of the protocol and be available for study visits over 3 years
- Control Subjects - Current/Ex Smokers
- A control subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female subjects, aged 40-75 years inclusive, who are free from significant disease as determined by history, physical examination and screening investigations
- Baseline (post-bronchodilator) FEV1 >85% of predicted normal. FEV1/FVC ratio >70%
- Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack years = (number of cigarettes per day / 20) x number of years smoked e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
- A signed and dated written informed consent is obtained prior to participation.
- Able to comply with the requirements of the protocol and be available for study visits over 3 years
- Control Subjects - Non-smokers
- A non-smoking control subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female subjects, aged 40-75 years inclusive, who are free from significant disease as determined by history, physical examination and screening investigations
- Baseline (post-bronchodilator) FEV1 >85% of predicted normal. FEV1/FVC ratio >70%
- Non-smokers with a smoking history of < 1 pack-year (number of pack years = (number of cigarettes per day / 20) x number of years smoked).
- A signed and dated written informed consent is obtained prior to participation.
- Able to comply with the requirements of the protocol and be available for study visits over 3 years
Who cannot join
- COPD Subjects
- A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Known respiratory disorders, or disorders identified at screening/visit 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
- Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus)
- Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
- Having undergone lung surgery (e.g. lung reduction, lung transplant)
Show all 28Show fewer
- Have cancer or have had cancer in the 5 years prior to study entry
- Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety
- Is enrolled in a long term blinded drug study (subjects in open label studies may be considered and subjects in short blinded studies (approx less than 12 weeks may be considered following consultation with sponsor) or a study where there is significant radiation exposure (e.g.: CT scans)
- Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse
- Have received a blood transfusion in the 4 weeks prior to study start
- Has experienced a moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks. All courses of oral corticosteroids and antibiotics must be completed at least 2 weeks before study start
- Is on long term oral corticosteroids (long term is considered use for more than 3 consecutive months)
- Unable to walk
- Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
- Control Subjects
- A control subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Known respiratory disorders, or disorders identified at screening/visit 1 including identification on the first CT scan (e.g.: COPD, asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis)
- Known history of significant inflammatory disease (eg rheumatoid arthritis and Lupus)
- Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
- Having undergone lung surgery (e.g. lung reduction, lung transplant)
- Have cancer or have had cancer in the 5 years prior to study entry
- Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study
- Is enrolled in a long term blinded drug study (subjects in open label studies may be considered and subjects in short blinded studies (approx less than 12 weeks may be considered following consultation with sponsor) or a study where there is significant radiation exposure (e.g.: CT scans)
- Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
- Have received a blood transfusion in the 4 weeks prior to study start
- Is on long term oral corticosteroids (long term is considered use for more than 3 consecutive months)
- Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
Trial locations and contacts
44 sites in 12 countries.
44 sites in 12 countries
United States20 sites
GSK Investigational Site
Baltimore, Maryland, 21224
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Boston, Massachusetts, 02135
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Hartford, Connecticut, 06105
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Lebanon, New Hampshire, 03756
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
New Haven, Connecticut, 06519
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Omaha, Nebraska, 68198
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Providence, Rhode Island, 02903
GSK Investigational Site
Rancho Mirage, California, 92270
GSK Investigational Site
Richmond, Virginia, 23225
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Torrance, California, 90502
Canada7 sites
GSK Investigational Site
Halifax, Nova Scotia, B3H 3A7
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5
GSK Investigational Site
Kingston, Ontario, K7L 2V7
GSK Investigational Site
Montreal, Quebec, H2X 2P4
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9
GSK Investigational Site
Vancouver, British Columbia, V6Z 1Y6
United Kingdom5 sites
GSK Investigational Site
Cambridge, CB2 2XY
GSK Investigational Site
Edinburgh, Midlothian, EH16 4SA
GSK Investigational Site
Liverpool, L9 7AL
GSK Investigational Site
London, NW3 2QG
GSK Investigational Site
Manchester, M23 9LT
Ukraine3 sites
GSK Investigational Site
Donetsk, 83003
GSK Investigational Site
Kiev, 03680
GSK Investigational Site
Kiev, 3680
Bulgaria2 sites
GSK Investigational Site
Pleven, 5800
GSK Investigational Site
Sofia, 1000
About this study
Official title: A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Novel endpoint determination
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), longitudinal, eclipse
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel endpoint determinationOther
Novel endpoint determination
| Study group | Role | What they receive |
|---|---|---|
| COPD subjects | Subjects with GOLD stage II-IV COPD Receives: Other: Novel endpoint determination | |
| Smoker controls | Subjects with smoking history but normal lung function Receives: Other: Novel endpoint determination | |
| Non-smoker controls | Normal healthy non-smokers Receives: Other: Novel endpoint determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying new patient subtypes and endpoints for COPD
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (81)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- 2,747 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292552
- Sponsor's protocol ID
- SCO104960
- Acronym
- ECLIPSE
- Status last verified
- Mar 2017
- First submitted
- 14 Feb 2006
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jordan RE, Keene SJ, Franssen FME, Fitzmaurice D, Adderley NJ, Dickens AP, Martin JT, Sitch AJ, Enocson A, Jowett S, Riley RD, Miller MR, Cooper BG, Turner A, Jolly K, Ayres JG, Stockley R, Greenfield S, Siebert S, Daley A, Cheng KK, de Vries F, Wouters EFM, Adab P. Prognostic score for predicting respiratory admissions among patients with chronic obstructive pulmonary disease in primary care: development and validation in population cohorts (Birmingham Lung Improvement Studies (BLISS)). BMJ. 2026 Mar 5;392:e084521. doi: 10.1136/bmj-2025-084521.
PubMed 41786356Zhang C, Konigsberg IR, He Y, Zhang J, Chikowore T, Feldman WB, Hu X, Ding Y, Pasaniuc B, Chang D, Chen Q, Lasky-Su JA, Hecker J, Tobin MD, Chen J, Kalra S, Pratte KA, Im HK, Wan ES, Manichaikul A, Silverman EK, Bowler RP, Lange LA, Ortega VE, Martin AR, Cho MH, Moll MR. Multi-trait polygenic scores for COPD and COPD exacerbations implicate druggable proteins. JCI Insight. 2026 Feb 19;11(7):e199951. doi: 10.1172/jci.insight.199951. eCollection 2026 Apr 8.
PubMed 41712304Zhang C, Konigsberg IR, He Y, Zhang J, Chikowore T, Feldman WB, Hu X, Ding Y, Pasaniuc B, Chang D, Chen Q, Lasky-Su JA, Hecker J, Tobin MD, Chen J, Kalra S, Pratte KA, Im HK, Wan ES, Manichaikul A, Silverman EK, Bowler RP, Lange LA, Ortega VE, Martin AR, Cho MH, Moll MR. Multi-Trait Polygenic Scores for COPD and COPD Exacerbations Implicate Druggable Proteins. medRxiv [Preprint]. 2025 Aug 26:2025.08.22.25334001. doi: 10.1101/2025.08.22.25334001.
PubMed 40909810Suryadevara R, Gregory A, Lu R, Xu Z, Masoomi A, Lutz SM, Berman S, Yun JH, Saferali A, Ryu MH, Moll M, Sin DD, Hersh CP, Silverman EK, Dy J, Pratte KA, Bowler RP, Castaldi PJ, Boueiz A; COPDGene investigators. Blood-based Transcriptomic and Proteomic Biomarkers of Emphysema. Am J Respir Crit Care Med. 2024 Feb 1;209(3):273-287. doi: 10.1164/rccm.202301-0067OC.
PubMed 37917913Govoni M, Bassi M, Santoro D, Donegan S, Singh D. Serum IL-8 as a Determinant of Response to Phosphodiesterase-4 Inhibition in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Sep 1;208(5):559-569. doi: 10.1164/rccm.202301-0071OC.
PubMed 37192443Hayden LP, Hobbs BD, Busch R, Cho MH, Liu M, Lopes-Ramos CM, Lomas DA, Bakke P, Gulsvik A, Silverman EK, Crapo JD, Beaty TH, Laird NM, Lange C, DeMeo DL. X chromosome associations with chronic obstructive pulmonary disease and related phenotypes: an X chromosome-wide association study. Respir Res. 2023 Feb 1;24(1):38. doi: 10.1186/s12931-023-02337-1.
PubMed 36726148Mathur R, Fang F, Gaddis N, Hancock DB, Cho MH, Hokanson JE, Bierut LJ, Lutz SM, Young K, Smith AV; NHLBI Trans-Omics for Precision Medicine (TOPMed) Consortium; Silverman EK, Page GP, Johnson EO. GAWMerge expands GWAS sample size and diversity by combining array-based genotyping and whole-genome sequencing. Commun Biol. 2022 Aug 11;5(1):806. doi: 10.1038/s42003-022-03738-6.
PubMed 35953715Driessen JHM, van Dort MJ, Romme EAPM, Wouters EFM, Smeenk FWJM, van Rietbergen B, van den Bergh JPW, Geusens P. Associations between bone attenuation and prevalent vertebral fractures on chest CT scans differ with vertebral fracture locations. Osteoporos Int. 2021 Sep;32(9):1869-1877. doi: 10.1007/s00198-020-05719-z. Epub 2021 Feb 16.
PubMed 33594489Ash SY, San Jose Estepar R, Fain SB, Tal-Singer R, Stockley RA, Nordenmark LH, Rennard S, Han MK, Merrill D, Humphries SM, Diaz AA, Mason SE, Rahaghi FN, Pistenmaa CL, Sciurba FC, Vegas-Sanchez-Ferrero G, Lynch DA, Washko GR; COPDGene Investigators and the COPD Biomarker Qualification Consortium. Relationship between Emphysema Progression at CT and Mortality in Ever-Smokers: Results from the COPDGene and ECLIPSE Cohorts. Radiology. 2021 Apr;299(1):222-231. doi: 10.1148/radiol.2021203531. Epub 2021 Feb 16.
PubMed 33591891Tang LYW, Coxson HO, Lam S, Leipsic J, Tam RC, Sin DD. Towards large-scale case-finding: training and validation of residual networks for detection of chronic obstructive pulmonary disease using low-dose CT. Lancet Digit Health. 2020 May;2(5):e259-e267. doi: 10.1016/S2589-7500(20)30064-9. Epub 2020 Apr 21.
PubMed 33328058Celli B, Locantore N, Yates JC, Bakke P, Calverley PMA, Crim C, Coxson HO, Lomas DA, MacNee W, Miller BE, Mullerova H, Rennard SI, Silverman EK, Wouters E, Tal-Singer R, Agusti A, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Markers of disease activity in COPD: an 8-year mortality study in the ECLIPSE cohort. Eur Respir J. 2021 Mar 25;57(3):2001339. doi: 10.1183/13993003.01339-2020. Print 2021 Mar.
PubMed 33303557Moll M, Lutz SM, Ghosh AJ, Sakornsakolpat P, Hersh CP, Beaty TH, Dudbridge F, Tobin MD, Mittleman MA, Silverman EK, Hobbs BD, Cho MH. Relative contributions of family history and a polygenic risk score on COPD and related outcomes: COPDGene and ECLIPSE studies. BMJ Open Respir Res. 2020 Nov;7(1):e000755. doi: 10.1136/bmjresp-2020-000755.
PubMed 33239407Langholm LL, Ronnow SR, Sand JMB, Leeming DJ, Tal-Singer R, Miller BE, Vestbo J, Karsdal MA, Manon-Jensen T. Increased von Willebrand Factor Processing in COPD, Reflecting Lung Epithelium Damage, Is Associated with Emphysema, Exacerbations and Elevated Mortality Risk. Int J Chron Obstruct Pulmon Dis. 2020 Mar 9;15:543-552. doi: 10.2147/COPD.S235673. eCollection 2020.
PubMed 32210548Kim W, Cho MH, Sakornsakolpat P, Lynch DA, Coxson HO, Tal-Singer R, Silverman EK, Beaty TH. DSP variants may be associated with longitudinal change in quantitative emphysema. Respir Res. 2019 Jul 19;20(1):160. doi: 10.1186/s12931-019-1097-8.
PubMed 31324189Ronnow SR, Sand JMB, Langholm LL, Manon-Jensen T, Karsdal MA, Tal-Singer R, Miller BE, Vestbo J, Leeming DJ. Type IV collagen turnover is predictive of mortality in COPD: a comparison to fibrinogen in a prospective analysis of the ECLIPSE cohort. Respir Res. 2019 Apr 1;20(1):63. doi: 10.1186/s12931-019-1026-x.
PubMed 30935391
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
- ClinicalTrials.gov ID
- NCT00292552
- Acronym / sponsor ID
- ECLIPSE / SCO104960
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), longitudinal, eclipse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,747 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Feb 2006 (estimated)
- 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.
This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD subjects | – | Other: Novel endpoint determinationSubjects with GOLD stage II-IV COPD |
| Smoker controls | – | Other: Novel endpoint determinationSubjects with smoking history but normal lung function |
| Non-smoker controls | – | Other: Novel endpoint determinationNormal healthy non-smokers |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD subjects and smoking and non-smoking controls
Key inclusion criteria (21 listed)
- COPD Subjects
- A COPD subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female subjects, aged 40-75 years inclusive
- A baseline (post-bronchodilator) FEV1 <80% of predicted normal and a baseline (post-bronchodilator) FEV1/FVC ratio 70%
- Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack years = (number of cigarettes per day / 20) x number of years smoked e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
Key exclusion criteria (28 listed)
- COPD Subjects
- A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Known respiratory disorders, or disorders identified at screening/visit 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
- Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus)
- Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel endpoint determinationNovel endpoint determination | Other | COPD subjects, Non-smoker controls, Smoker controls |
Primary outcome
Identifying new patient subtypes and endpoints for COPD
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Derived from this study: PubMed 41786356Jordan RE, Keene SJ, Franssen FME, Fitzmaurice D, Adderley NJ, Dickens AP, Martin JT, Sitch AJ, Enocson A, Jowett S, Riley RD, Miller MR, Cooper BG, Turner A, Jolly K, Ayres JG, Stockley R, Greenfield S, Siebert S, Daley A, Cheng KK, de Vries F, Wouters EFM, Adab P. Prognostic score for predicting respiratory admissions among patients with chronic obstructive pulmonary disease in primary care: development and validation in population cohorts (Birmingham Lung Improvement Studies (BLISS)). BMJ. 2026 Mar 5;392:e084521. doi: 10.1136/bmj-2025-084521.
- Derived from this study: PubMed 41712304Zhang C, Konigsberg IR, He Y, Zhang J, Chikowore T, Feldman WB, Hu X, Ding Y, Pasaniuc B, Chang D, Chen Q, Lasky-Su JA, Hecker J, Tobin MD, Chen J, Kalra S, Pratte KA, Im HK, Wan ES, Manichaikul A, Silverman EK, Bowler RP, Lange LA, Ortega VE, Martin AR, Cho MH, Moll MR. Multi-trait polygenic scores for COPD and COPD exacerbations implicate druggable proteins. JCI Insight. 2026 Feb 19;11(7):e199951. doi: 10.1172/jci.insight.199951. eCollection 2026 Apr 8.
- Derived from this study: PubMed 40909810Zhang C, Konigsberg IR, He Y, Zhang J, Chikowore T, Feldman WB, Hu X, Ding Y, Pasaniuc B, Chang D, Chen Q, Lasky-Su JA, Hecker J, Tobin MD, Chen J, Kalra S, Pratte KA, Im HK, Wan ES, Manichaikul A, Silverman EK, Bowler RP, Lange LA, Ortega VE, Martin AR, Cho MH, Moll MR. Multi-Trait Polygenic Scores for COPD and COPD Exacerbations Implicate Druggable Proteins. medRxiv [Preprint]. 2025 Aug 26:2025.08.22.25334001. doi: 10.1101/2025.08.22.25334001.
- Derived from this study: PubMed 37917913Suryadevara R, Gregory A, Lu R, Xu Z, Masoomi A, Lutz SM, Berman S, Yun JH, Saferali A, Ryu MH, Moll M, Sin DD, Hersh CP, Silverman EK, Dy J, Pratte KA, Bowler RP, Castaldi PJ, Boueiz A; COPDGene investigators. Blood-based Transcriptomic and Proteomic Biomarkers of Emphysema. Am J Respir Crit Care Med. 2024 Feb 1;209(3):273-287. doi: 10.1164/rccm.202301-0067OC.
- Derived from this study: PubMed 37192443Govoni M, Bassi M, Santoro D, Donegan S, Singh D. Serum IL-8 as a Determinant of Response to Phosphodiesterase-4 Inhibition in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Sep 1;208(5):559-569. doi: 10.1164/rccm.202301-0071OC.
- Derived from this study: PubMed 36726148Hayden LP, Hobbs BD, Busch R, Cho MH, Liu M, Lopes-Ramos CM, Lomas DA, Bakke P, Gulsvik A, Silverman EK, Crapo JD, Beaty TH, Laird NM, Lange C, DeMeo DL. X chromosome associations with chronic obstructive pulmonary disease and related phenotypes: an X chromosome-wide association study. Respir Res. 2023 Feb 1;24(1):38. doi: 10.1186/s12931-023-02337-1.
- Derived from this study: PubMed 35953715Mathur R, Fang F, Gaddis N, Hancock DB, Cho MH, Hokanson JE, Bierut LJ, Lutz SM, Young K, Smith AV; NHLBI Trans-Omics for Precision Medicine (TOPMed) Consortium; Silverman EK, Page GP, Johnson EO. GAWMerge expands GWAS sample size and diversity by combining array-based genotyping and whole-genome sequencing. Commun Biol. 2022 Aug 11;5(1):806. doi: 10.1038/s42003-022-03738-6.
- Derived from this study: PubMed 33594489Driessen JHM, van Dort MJ, Romme EAPM, Wouters EFM, Smeenk FWJM, van Rietbergen B, van den Bergh JPW, Geusens P. Associations between bone attenuation and prevalent vertebral fractures on chest CT scans differ with vertebral fracture locations. Osteoporos Int. 2021 Sep;32(9):1869-1877. doi: 10.1007/s00198-020-05719-z. Epub 2021 Feb 16.
- Derived from this study: PubMed 33591891Ash SY, San Jose Estepar R, Fain SB, Tal-Singer R, Stockley RA, Nordenmark LH, Rennard S, Han MK, Merrill D, Humphries SM, Diaz AA, Mason SE, Rahaghi FN, Pistenmaa CL, Sciurba FC, Vegas-Sanchez-Ferrero G, Lynch DA, Washko GR; COPDGene Investigators and the COPD Biomarker Qualification Consortium. Relationship between Emphysema Progression at CT and Mortality in Ever-Smokers: Results from the COPDGene and ECLIPSE Cohorts. Radiology. 2021 Apr;299(1):222-231. doi: 10.1148/radiol.2021203531. Epub 2021 Feb 16.
- Derived from this study: PubMed 33328058Tang LYW, Coxson HO, Lam S, Leipsic J, Tam RC, Sin DD. Towards large-scale case-finding: training and validation of residual networks for detection of chronic obstructive pulmonary disease using low-dose CT. Lancet Digit Health. 2020 May;2(5):e259-e267. doi: 10.1016/S2589-7500(20)30064-9. Epub 2020 Apr 21.
- Derived from this study: PubMed 33303557Celli B, Locantore N, Yates JC, Bakke P, Calverley PMA, Crim C, Coxson HO, Lomas DA, MacNee W, Miller BE, Mullerova H, Rennard SI, Silverman EK, Wouters E, Tal-Singer R, Agusti A, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Markers of disease activity in COPD: an 8-year mortality study in the ECLIPSE cohort. Eur Respir J. 2021 Mar 25;57(3):2001339. doi: 10.1183/13993003.01339-2020. Print 2021 Mar.
- Derived from this study: PubMed 33239407Moll M, Lutz SM, Ghosh AJ, Sakornsakolpat P, Hersh CP, Beaty TH, Dudbridge F, Tobin MD, Mittleman MA, Silverman EK, Hobbs BD, Cho MH. Relative contributions of family history and a polygenic risk score on COPD and related outcomes: COPDGene and ECLIPSE studies. BMJ Open Respir Res. 2020 Nov;7(1):e000755. doi: 10.1136/bmjresp-2020-000755.
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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
GSK Clinical Trials study director
GlaxoSmithKline
44 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 44 sites in 12 countries.
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 21 inclusion and 28 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: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Canada, United Kingdom, Ukraine, Bulgaria and 7 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying new patient subtypes and endpoints for COPD (time frame: 3 years). 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 NCT00292552, which also lists 81 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 23 Mar 2017.