COSMIC: Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease

Sponsor
Karolinska Institutet (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02627872
Collaborator
University of California, San Francisco (Other), Göteborg University (Other), University of Bergen (Other), University of Oulu (Other), Kyoto University (Other), Swedish Heart Lung Foundation (Other), The Swedish Research Council (Other), Region Stockholm (Other), Vinnova (Other), Swedish Foundation for Strategic Research (Other), European Union (Other)
120
1
213.1
0.6

Study Details

Study Description

Brief 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 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

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease
Study Start Date :
Mar 1, 2007
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Forced expiratory volume in 1 second (FEV1) [Measured at baseline and up to 10 year follow-up]

  2. Emphysema, as shown on chest CT scan [Measured at baseline and up to 10 year follow-up]

  3. Airway wall thickness on chest CT scan [Measured at baseline and up to 10 year follow-up]

  4. COPD status (COPD participants versus control group participants) [Measured at baseline and up to 10 year follow-up]

  5. Molecular gender differences [Measured at baseline]

    Molecular levels investigated: mRNA, miRNA, proteome, metabolome, lipidome

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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)

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska Institutet/Karolinska University Hospital Solna Stockholm Sverige Sweden 17176

Sponsors and Collaborators

  • Karolinska Institutet
  • 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Asa Wheelock, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02627872
Other Study ID Numbers:
  • 2006/959-31/1
First Posted:
Dec 11, 2015
Last Update Posted:
Oct 14, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2020