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

November 24, 2022 updated by: Asa Wheelock, Karolinska Institutet
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Sverige
      • Stockholm, Sverige, Sweden, 17176
        • Karolinska Institutet/Karolinska University Hospital Solna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants from all groups are recruited from the general population through advertisements.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced expiratory volume in 1 second (FEV1)
Time Frame: Measured at baseline and up to 10 year follow-up
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
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
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
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
Measured at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council
Göteborg University
University of Bergen
University of California, San Francisco
Region Stockholm
University of Oulu
European Union
Swedish Heart Lung Foundation
Vinnova
Kyoto University
Swedish Foundation for Strategic Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2021

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 24, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/959-31/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The deidentified clinical phenotype data has been disseminated through peer reviewed publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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