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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California, San Francisco
Göteborg University
University of Bergen
University of Oulu
Kyoto University
Swedish Heart Lung Foundation
The Swedish Research Council
Stockholm County Council, Sweden
Vinnova
Swedish Foundation for Strategic Research (SSF)
European Union
Information provided by (Responsible Party):
Asa Wheelock, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02627872
First received: December 9, 2015
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
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.

Condition
Chronic Obstructive Pulmonary Disease Emphysema Chronic Bronchitis Chronic Airways Obstruction Smoking

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Asa Wheelock, Karolinska Institutet:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
Bronchoalveolar lavage (BAL) cells, BAL fluid, bronchial biopsies, airway epithelial brushings, serum, plasma, and blood cells have been collected.

Enrollment: 120
Study Start Date: March 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants from all groups are recruited from the general population through advertisements.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02627872

Locations
Sweden
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
Stockholm County Council, Sweden
Vinnova
Swedish Foundation for Strategic Research (SSF)
European Union
  More Information

Publications:

Responsible Party: Asa Wheelock, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02627872     History of Changes
Other Study ID Numbers: 2006/959-31/1
Study First Received: December 9, 2015
Last Updated: January 31, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: The deidentified clinical phenotype data has been disseminated through peer reviewed publication

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Bronchitis
Bronchitis, Chronic
Airway Obstruction
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections
Respiratory Insufficiency
Respiration Disorders

ClinicalTrials.gov processed this record on June 23, 2017