Chronic Obstructive Pulmonary DiseaseCOSMICNCT02627872
Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which primarily increases among the female population. The purpose of this study is to perform in-depth clinical and molecular characterizations of early stage COPD patients, as well as healthy never-smoker and at-risk smoking control… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants from all groups are recruited from the general population through advertisements.
Who may be able to join
- For smokers, at least 10 pack-years of cigarette smoking
- For smokers, at least 10 cigarettes/day the past 6 months before study entry Spirometry that meets stage I-II of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages (postbronchodilator forced expiratory volume in 1 second (FEV1) of 50%-100% of predicted level and FEV1/forced vital capacity [FEV1/FVC] less than 0.7) or normal (postbronchodilator FEV1 greater than 80% of predicted level and forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] greater than 0.7)
Who cannot join
- Other lung diseases
- Atopy (defined as positive specific IgE test)
- Asthma
- Received antibiotics for a COPD exacerbation in the 3 months prior to study entry
- Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry
- Significant ischaemic heart disease or arrhythmia
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet/Karolinska University Hospital Solna
Stockholm, Sverige, 17176
About this study
Chronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which primarily increases among the female population. The purpose of this study is to perform in-depth clinical and molecular characterizations of early stage COPD patients, as well as healthy never-smoker and at-risk smoking control populations to identify molecularly related subgroups patients, including gender-related sub-phenotypes of COPD.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an umbrella diagnosis defined by obstructive lung function impairments, and is likely to be caused by a multitude of etiologies including environmental exposures, genetic predispositions and developmental factors. Due to the heterogeneity of the disease, molecular and mechanistic sub-phenotyping of COPD represents an essential step to facilitate the development of relevant diagnostic and treatment options for this constantly growing patient group. In the Karolinska COSMIC study, the investigators are investigating molecular sub-phenotypes of smoking-induced COPD. A particular focus relates to recent epidemiological indications of gender differences in both incidence and severity of disease, with post-menopausal women being at greatest risk. The study encompasses profiling of mRNA, miRNA, proteomes, metabolomes and lipid mediators of from multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and bronchoalveolar exudates) using a range of 'omics platforms, in combination with extensive clinical phenotyping of early stage COPD patients, never-smokers, and smokers with normal lung function from both genders. The primary objective of the study is to identify molecular sub-phenotypes of patients with COPD, specifically by correlating clinical phenotypes multi-molecular 'omics profiling from multiple lung compartments of early stage COPD patients compared to healthy and at-risk control populations. Secondary goals involve identification of subsets of prognostic/diagnostic biomarkers for classification of the defined subgroups, as well as relevant pharmaceutical targets.
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis, Chronic Airways Obstruction, Smoking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic, Smoking
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 |
|---|---|---|
| COPD patients (GOLD I-II) | Participants with mild-to-moderate COPD (GOLD I-II) | |
| Smoker Control Group | Actively smoking participants with normal lung function (do not have COPD) | |
| Healthy Never-smoker Control Group | Healthy participants that never have smoked |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second (FEV1)
Measured: Measured at baseline and up to 10 year follow-up
Emphysema, as shown on chest CT scan
Measured: Measured at baseline and up to 10 year follow-up
Airway wall thickness on chest CT scan
Measured: Measured at baseline and up to 10 year follow-up
COPD status (COPD participants versus control group participants)
Measured: Measured at baseline and up to 10 year follow-up
Molecular gender differences
Molecular levels investigated: mRNA, miRNA, proteome, metabolome, lipidome
Measured: Measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMar 2007
- Primary completionDec 2021
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Göteborg University, University of Bergen, University of Oulu, Kyoto University, Swedish Heart Lung Foundation, The Swedish Research Council, Region Stockholm, Vinnova, Swedish Foundation for Strategic Research, European Union
- Responsible party
- Principal investigator, Asa Wheelock, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627872
- Sponsor's protocol ID
- 2006/959-31/1
- Acronym
- COSMIC
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2015
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The deidentified clinical phenotype data has been disseminated through peer reviewed publication
Publications
Sandberg A, Skold CM, Grunewald J, Eklund A, Wheelock AM. Assessing recent smoking status by measuring exhaled carbon monoxide levels. PLoS One. 2011;6(12):e28864. doi: 10.1371/journal.pone.0028864. Epub 2011 Dec 16.
PubMed 22194931Forsslund H, Mikko M, Karimi R, Grunewald J, Wheelock AM, Wahlstrom J, Skold CM. Distribution of T-cell subsets in BAL fluid of patients with mild to moderate COPD depends on current smoking status and not airway obstruction. Chest. 2014 Apr;145(4):711-722. doi: 10.1378/chest.13-0873.
PubMed 24264182Karimi R, Tornling G, Forsslund H, Mikko M, Wheelock A, Nyren S, Skold CM. Lung density on high resolution computer tomography (HRCT) reflects degree of inflammation in smokers. Respir Res. 2014 Feb 24;15(1):23. doi: 10.1186/1465-9921-15-23.
PubMed 24564813Kohler M, Sandberg A, Kjellqvist S, Thomas A, Karimi R, Nyren S, Eklund A, Thevis M, Skold CM, Wheelock AM. Gender differences in the bronchoalveolar lavage cell proteome of patients with chronic obstructive pulmonary disease. J Allergy Clin Immunol. 2013 Mar;131(3):743-51. doi: 10.1016/j.jaci.2012.09.024. Epub 2012 Nov 10.
PubMed 23146379Mikko M, Forsslund H, Cui L, Grunewald J, Wheelock AM, Wahlstrom J, Skold CM. Increased intraepithelial (CD103+) CD8+ T cells in the airways of smokers with and without chronic obstructive pulmonary disease. Immunobiology. 2013 Feb;218(2):225-31. doi: 10.1016/j.imbio.2012.04.012. Epub 2012 May 4.
PubMed 22652413Balgoma D, Yang M, Sjodin M, Snowden S, Karimi R, Levanen B, Merikallio H, Kaarteenaho R, Palmberg L, Larsson K, Erle DJ, Dahlen SE, Dahlen B, Skold CM, Wheelock AM, Wheelock CE. Linoleic acid-derived lipid mediators increase in a female-dominated subphenotype of COPD. Eur Respir J. 2016 Jun;47(6):1645-56. doi: 10.1183/13993003.01080-2015. Epub 2016 Mar 10.
PubMed 26965288Forsslund H, Yang M, Mikko M, Karimi R, Nyren S, Engvall B, Grunewald J, Merikallio H, Kaarteenaho R, Wahlstrom J, Wheelock AM, Skold CM. Gender differences in the T-cell profiles of the airways in COPD patients associated with clinical phenotypes. Int J Chron Obstruct Pulmon Dis. 2016 Dec 20;12:35-48. doi: 10.2147/COPD.S113625. eCollection 2017.
PubMed 28053515Karimi R, Tornling G, Forsslund H, Mikko M, Wheelock AM, Nyren S, Skold CM. Differences in regional air trapping in current smokers with normal spirometry. Eur Respir J. 2017 Jan 25;49(1):1600345. doi: 10.1183/13993003.00345-2016. Print 2017 Jan.
PubMed 28122862Naz S, Kolmert J, Yang M, Reinke SN, Kamleh MA, Snowden S, Heyder T, Levanen B, Erle DJ, Skold CM, Wheelock AM, Wheelock CE. Metabolomics analysis identifies sex-associated metabotypes of oxidative stress and the autotaxin-lysoPA axis in COPD. Eur Respir J. 2017 Jun 22;49(6):1602322. doi: 10.1183/13993003.02322-2016. Print 2017 Jun.
PubMed 28642310Li CX, Wheelock CE, Skold CM, Wheelock AM. Integration of multi-omics datasets enables molecular classification of COPD. Eur Respir J. 2018 May 10;51(5):1701930. doi: 10.1183/13993003.01930-2017. Print 2018 May.
PubMed 29545283Naz S, Bhat M, Stahl S, Forsslund H, Skold CM, Wheelock AM, Wheelock CE. Dysregulation of the Tryptophan Pathway Evidences Gender Differences in COPD. Metabolites. 2019 Oct 1;9(10):212. doi: 10.3390/metabo9100212.
PubMed 31581603Fuchs D, Hamberg M, Skold CM, Wheelock AM, Wheelock CE. An LC-MS/MS workflow to characterize 16 regio- and stereoisomeric trihydroxyoctadecenoic acids. J Lipid Res. 2018 Oct;59(10):2025-2033. doi: 10.1194/jlr.D087429. Epub 2018 Jul 31.
PubMed 30065010Che KF, Tufvesson E, Tengvall S, Lappi-Blanco E, Kaarteenaho R, Levanen B, Ekberg M, Brauner A, Wheelock AM, Bjermer L, Skold CM, Linden A. The neutrophil-mobilizing cytokine interleukin-26 in the airways of long-term tobacco smokers. Clin Sci (Lond). 2018 May 20;132(9):959-983. doi: 10.1042/CS20180057. Print 2018 May 23.
PubMed 29780024Che KF, Kaarteenaho R, Lappi-Blanco E, Levanen B, Sun J, Wheelock A, Palmberg L, Skold CM, Linden A. Interleukin-26 Production in Human Primary Bronchial Epithelial Cells in Response to Viral Stimulation: Modulation by Th17 cytokines. Mol Med. 2017 Oct;23:247-257. doi: 10.2119/molmed.2016.00064. Epub 2017 Aug 29.
PubMed 28853490Merikallio H, Kaarteenaho R, Linden S, Padra M, Karimi R, Li CX, Lappi-Blanco E, Wheelock AM, Skold MC. Smoking-associated increase in mucins 1 and 4 in human airways. Respir Res. 2020 Sep 18;21(1):239. doi: 10.1186/s12931-020-01498-7.
PubMed 32948202
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02627872
- Acronym / sponsor ID
- COSMIC / 2006/959-31/1
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis, Chronic Airways Obstruction, Smoking
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Göteborg University, University of Bergen, University of Oulu, Kyoto University, Swedish Heart Lung Foundation, The Swedish Research Council, Region Stockholm, Vinnova, Swedish Foundation for Strategic Research, European Union
- Study start
- Mar 2007
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 11 Dec 2015 (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.
Chronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which primarily increases among the female population. The purpose of this study is to perform in-depth clinical and molecular characterizations of early stage COPD patients, as well as healthy never-smoker and at-risk smoking control populations to identify molecularly related subgroups patients, including gender-related sub-phenotypes of COPD.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an umbrella diagnosis defined by obstructive lung function impairments, and is likely to be caused by a multitude of etiologies including environmental exposures, genetic predispositions and developmental factors. Due to the heterogeneity of the disease, molecular and mechanistic sub-phenotyping of COPD represents an essential step to facilitate the development of relevant diagnostic and treatment options for this constantly growing patient group. In the Karolinska COSMIC study, the investigators are investigating molecular sub-phenotypes of smoking-induced COPD. A particular focus relates to recent epidemiological indications of gender differences in both incidence and severity of disease, with post-menopausal women being at greatest risk. The study encompasses profiling of mRNA, miRNA, proteomes, metabolomes and lipid mediators of from multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and bronchoalveolar exudates) using a range of 'omics platforms, in combination with extensive clinical phenotyping of early stage COPD patients, never-smokers, and smokers with normal lung function from both genders. The primary objective of the study is to identify molecular sub-phenotypes of patients with COPD, specifically by correlating clinical phenotypes multi-molecular 'omics profiling from multiple lung compartments of early stage COPD patients compared to healthy and at-risk control populations. Secondary goals involve identification of subsets of prognostic/diagnostic biomarkers for classification of the defined subgroups, as well as relevant pharmaceutical targets.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD patients (GOLD I-II) | – | –Participants with mild-to-moderate COPD (GOLD I-II) |
| Smoker Control Group | – | –Actively smoking participants with normal lung function (do not have COPD) |
| Healthy Never-smoker Control Group | – | –Healthy participants that never have smoked |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from all groups are recruited from the general population through advertisements.
Key inclusion criteria (2 listed)
- For smokers, at least 10 pack-years of cigarette smoking
- For smokers, at least 10 cigarettes/day the past 6 months before study entry Spirometry that meets stage I-II of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages (postbronchodilator forced expiratory volume in 1 second (FEV1) of 50%-100% of predicted level and FEV1/forced vital capacity [FEV1/FVC] less than 0.7) or normal (postbronchodilator FEV1 greater than 80% of predicted level and forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] greater than 0.7)
Key exclusion criteria (6 listed)
- Other lung diseases
- Atopy (defined as positive specific IgE test)
- Asthma
- Received antibiotics for a COPD exacerbation in the 3 months prior to study entry
- Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry
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
Forced expiratory volume in 1 second (FEV1)
Time frame: Measured at baseline and up to 10 year follow-up
Emphysema, as shown on chest CT scan
Time frame: Measured at baseline and up to 10 year follow-up
Airway wall thickness on chest CT scan
Time frame: Measured at baseline and up to 10 year follow-up
COPD status (COPD participants versus control group participants)
Time frame: Measured at baseline and up to 10 year follow-up
Molecular gender differences
Time frame: Measured at baseline
Molecular levels investigated: mRNA, miRNA, proteome, metabolome, lipidome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 22194931Sandberg A, Skold CM, Grunewald J, Eklund A, Wheelock AM. Assessing recent smoking status by measuring exhaled carbon monoxide levels. PLoS One. 2011;6(12):e28864. doi: 10.1371/journal.pone.0028864. Epub 2011 Dec 16.
- Results publication: PubMed 24264182Forsslund H, Mikko M, Karimi R, Grunewald J, Wheelock AM, Wahlstrom J, Skold CM. Distribution of T-cell subsets in BAL fluid of patients with mild to moderate COPD depends on current smoking status and not airway obstruction. Chest. 2014 Apr;145(4):711-722. doi: 10.1378/chest.13-0873.
- Results publication: PubMed 24564813Karimi R, Tornling G, Forsslund H, Mikko M, Wheelock A, Nyren S, Skold CM. Lung density on high resolution computer tomography (HRCT) reflects degree of inflammation in smokers. Respir Res. 2014 Feb 24;15(1):23. doi: 10.1186/1465-9921-15-23.
- Results publication: PubMed 23146379Kohler M, Sandberg A, Kjellqvist S, Thomas A, Karimi R, Nyren S, Eklund A, Thevis M, Skold CM, Wheelock AM. Gender differences in the bronchoalveolar lavage cell proteome of patients with chronic obstructive pulmonary disease. J Allergy Clin Immunol. 2013 Mar;131(3):743-51. doi: 10.1016/j.jaci.2012.09.024. Epub 2012 Nov 10.
- Results publication: PubMed 22652413Mikko M, Forsslund H, Cui L, Grunewald J, Wheelock AM, Wahlstrom J, Skold CM. Increased intraepithelial (CD103+) CD8+ T cells in the airways of smokers with and without chronic obstructive pulmonary disease. Immunobiology. 2013 Feb;218(2):225-31. doi: 10.1016/j.imbio.2012.04.012. Epub 2012 May 4.
- Results publication: PubMed 26965288Balgoma D, Yang M, Sjodin M, Snowden S, Karimi R, Levanen B, Merikallio H, Kaarteenaho R, Palmberg L, Larsson K, Erle DJ, Dahlen SE, Dahlen B, Skold CM, Wheelock AM, Wheelock CE. Linoleic acid-derived lipid mediators increase in a female-dominated subphenotype of COPD. Eur Respir J. 2016 Jun;47(6):1645-56. doi: 10.1183/13993003.01080-2015. Epub 2016 Mar 10.
- Results publication: PubMed 28053515Forsslund H, Yang M, Mikko M, Karimi R, Nyren S, Engvall B, Grunewald J, Merikallio H, Kaarteenaho R, Wahlstrom J, Wheelock AM, Skold CM. Gender differences in the T-cell profiles of the airways in COPD patients associated with clinical phenotypes. Int J Chron Obstruct Pulmon Dis. 2016 Dec 20;12:35-48. doi: 10.2147/COPD.S113625. eCollection 2017.
- Results publication: PubMed 28122862Karimi R, Tornling G, Forsslund H, Mikko M, Wheelock AM, Nyren S, Skold CM. Differences in regional air trapping in current smokers with normal spirometry. Eur Respir J. 2017 Jan 25;49(1):1600345. doi: 10.1183/13993003.00345-2016. Print 2017 Jan.
- Results publication: PubMed 28642310Naz S, Kolmert J, Yang M, Reinke SN, Kamleh MA, Snowden S, Heyder T, Levanen B, Erle DJ, Skold CM, Wheelock AM, Wheelock CE. Metabolomics analysis identifies sex-associated metabotypes of oxidative stress and the autotaxin-lysoPA axis in COPD. Eur Respir J. 2017 Jun 22;49(6):1602322. doi: 10.1183/13993003.02322-2016. Print 2017 Jun.
- Results publication: PubMed 29545283Li CX, Wheelock CE, Skold CM, Wheelock AM. Integration of multi-omics datasets enables molecular classification of COPD. Eur Respir J. 2018 May 10;51(5):1701930. doi: 10.1183/13993003.01930-2017. Print 2018 May.
- Results publication: PubMed 31581603Naz S, Bhat M, Stahl S, Forsslund H, Skold CM, Wheelock AM, Wheelock CE. Dysregulation of the Tryptophan Pathway Evidences Gender Differences in COPD. Metabolites. 2019 Oct 1;9(10):212. doi: 10.3390/metabo9100212.
- Results publication: PubMed 30065010Fuchs D, Hamberg M, Skold CM, Wheelock AM, Wheelock CE. An LC-MS/MS workflow to characterize 16 regio- and stereoisomeric trihydroxyoctadecenoic acids. J Lipid Res. 2018 Oct;59(10):2025-2033. doi: 10.1194/jlr.D087429. Epub 2018 Jul 31.
- Individual participant dataSharing planned: Yes. The deidentified clinical phenotype data has been disseminated through peer reviewed publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Forced expiratory volume in 1 second (FEV1) (time frame: Measured at baseline and up to 10 year follow-up). The study lists 5 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 NCT02627872, which also lists 17 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 28 Mar 2025.