Chronic Obstructive Pulmonary Disease (COPD) Biomarker Identification Study
Condition: COPD
MeSH terms: Inflammation
Study type: Observational

Summary: 
      Chronic obstructive pulmonary disease (COPD) is a common inflammatory disease of the airway
      affecting approximately 10% of individuals aged 40 years or more with a smoking history. The
      disease is characterized by an increase in numbers of airway white blood cells (neutrophils,
      lymphocytes and monocytes). Stimulation of white blood cells results in the release of
      different agents of inflammation. Some of these agents give an indication of the presence or
      severity of a disease when measured.

      This case control study will be conducted at The Heart Lung Centre, London, UK. The study
      aims to determine biomarkers for the differentiation of subjects with COPD (GOLD Stage 1-2
      and who are current smokers with a ≥ 10 pack year smoking history) and three matched control
      groups: one of non-smoking subjects (never smoked), one of ex-smokers and one of current
      smokers. COPD subjects will be matched to the non-COPD subjects by gender, age and ethnicity.

      The study will include a range of physiological measurements including lung function,
      computerized tomography scans (CT scans), cardio pulmonary exercise test and computerized
      multichannel lung sounds analysis (Stethographics). In addition, lung inflammation will be
      assessed by cellular and molecular biomarkers using e.g. transcriptomics and proteomics
      technologies.
    

Detailed description: 
      At the screening visit, subject consent will be obtained prior to conducting any study
      related procedures. Informed consent may be obtained on registration/review visit at the
      Centre where it is conducted and thus prior to visit 1.

      The screening visit will involve obtaining demographic data and medical history information
      as well as performing safety assessments such as vital sign measurements, electrocardiogram
      (ECG), and clinical laboratory tests. An induced sputum sample will be obtained to ensure
      that subjects can produce an adequate sputum sample. Smokers will receive information on
      smoking cessation at the screening visit and follow-up telephone call.

      Subjects will come back to the center on up to four further occasions if they meet the
      inclusion/exclusion criteria at screening:

        -  visit 2: 4 to 21 days after screening,

        -  visit 3: 3-14 days post visit 2, and

        -  visit 4: 3-14 days post visit 3.

      A follow-up telephone call will be conducted 3-10 days post visit 4.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In this study, male and female subjects aged between 40-70 years will be included. All
        subjects must be matched by ethnicity, gender and age (within 5 years) of the subjects with
        COPD recruited in the study.
      
Biospecimen description: 
      Proteomic investigations: Induced Sputum

      Transcriptomics investigations (mRNA and micro RNA): Whole Blood, Nasal Scrapes, Induced
      sputum cell pellet

      Genomic DNA sequencing: Whole blood

      Lipidomics: Whole blood
    
Keywords: COPD; Biomarkers; Cigarette Smoke; Lung Inflammation; FEV; Sputum