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Clinical Trials in Sweden / NCT02627872
Active, not recruiting Observational

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

NCT02627872 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Observational
Started
2007-03
Last updated
2025-03-28

Condition(s) studied

Chronic Obstructive Pulmonary DiseaseEmphysemaChronic BronchitisChronic Airways ObstructionSmoking

Study 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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Forced expiratory volume in 1 second (FEV1) — Measured at baseline and up to 10 year follow-up
  • Emphysema, as shown on chest CT scan — Measured at baseline and up to 10 year follow-up
  • Airway wall thickness on chest CT scan — Measured at baseline and up to 10 year follow-up
  • COPD status (COPD participants versus control group participants) — Measured at baseline and up to 10 year follow-up
  • Molecular gender differences — Measured at baseline
    Molecular levels investigated: mRNA, miRNA, proteome, metabolome, lipidome

Trial sites (1)

FacilityCityRegionStatus
Karolinska Institutet/Karolinska University Hospital Solna Stockholm Sverige

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Other trials for the same condition

An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study Enrolling by invitation
Vowel Segmentation for Classification of Chronic Obstructive Pulmonary Disease Using Machine Learning Active, not recruiting
BROnchoalveolar Investigations of Never-smokers With Chronic Obstruction From the Swedish CardioPulmonary bioImage Study Active, not recruiting
Interactive 3D Visualization Technique Used in Pulmonary Rehabilitation Programme in COPD Active, not recruiting
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02627872 on ClinicalTrials.gov ↗ ← All trials in Sweden