Table 5 Summary of ongoing or completed longitudinal observational COPD studies
Observational study | Population under study | Key characteristics | Key outcomes | Duration of study (number of visits post-screening) | |
|---|---|---|---|---|---|
COPD subjects | Control subjects | ||||
FOOTPRINTS [13] | 382 patients with COPD: • GOLD 1: 123 • GOLD 2: 130 • GOLD 3: 129 19 patients with COPD and A1ATD 62 EwAL limitation | Age (years): • 40–70 • COPD and A1ATD: 30–70 COPD & A1ATD smoking history ≥ 10 pack-years Subjects with asthma excluded | • EwAL • Smoking history ≥ 20 pack-years • FEV1 ≥ 80% predicted • FEV1/FVC ≥ LLN Post DLCO ≥ 70% predicted at Visit 1 | • Lung function • CT imaging • Symptom questionnaires • 6MWT • Soluble biomarkers (serum, plasma, and sputum) | 3 years (5) |
 > 10,000 current smokers (with or without COPD) and non-smoker subjects across full spectrum of COPD disease severities | • Aged 45–80 years • ≥ 10 pack-year smoking history • Included subjects with asthma | • Non-smokers and smokers without COPD aged 45–80 years • ≥ 10 pack-year smoking history except non-smokers • Included subjects with asthma | • Lung function testing • CT imaging • Medical history • SGRQ • 6MWT • Genomic analysis, serum and plasma samples for proteomics | 10 years (2) | |
ECLIPSE [3] | • > 2000 COPD subjects with GOLD 2–4 COPD • 343 smoking and 223 non-smoking control subjects | • Aged 40–75 years • ≥ 10 pack-year smoking history • Baseline post-bronchodilator FEV1 of < 80% predicted and FEV1/FVC ≤ 0.7 | • Aged 40–75 years • Baseline post-bronchodilator FEV1 of > 85% predicted and FEV1/FVC of > 0.7 • Current or ex-smokers with a smoking history ≥ 10 pack-years (smoking controls) or non-smokers with a smoking history of < 1 pack-year | • Lung function testing • Chest CT • Biomarker measurement (blood, sputum, urine and exhaled breath condensate) • Health outcomes, body impedance and resting oxygen saturation • Symptom questionnaires • 6MWT | 3 years (8) |
SPIROMICS [5] |  > 3200 participants in four strata:  1. Non-smokers  2. Smokers without airflow obstruction  3. Smokers with mild/moderate COPD  4. Smokers with severe COPD | Aged 40–80 years • > 20 pack-year smoking history • FEV1/FVC < 0.7 • FEV1 > 50% predicted for mild/moderate COPD and < 50% predicted for severe | Aged 40–80 years • < 1 pack-year smoking history for non-smokers • > 20 pack-year smoking history for smokers without airflow limitation • FEV1/FVC > 0.7 • FVC > LLN | • Lung function testing • CT imaging • 6MWT • Biomarker measurement (blood and sputum) • Symptom questionnaires • Medical history | 3 years (3) |
COSYCONET [6] (NCT01245933) | • 2291 patients across COPD GOLD stages 1–4 • 206 patients with GOLD “0”a | • Aged 40–90 years • 8%/35%/32%/9% GOLD 1–4 • 24%/68%/8% currently smoking/ex-smokers/never-smokers • Mean of 40–50 pack-years for currently smoking and ex-smokers | No control population in this study | • Lung function testing • Chest CT and MRIb • 6MWT • Body impedance • Symptom and health questionnaires • Biomarker measurement (blood and urine) | 9 years (7) |
CanCOLD [7] | • 2295 never-smokers • 2598 ever-smokers | • Aged ≥ 40 years • > 20 pack-year smoking history in ever-smokers • Never-smokers accounted for 29% of COPD patients | No control population in this study | • Lung function testing • Chest CT • Respiratory symptoms and exacerbations | 4 years (visits not listed) |
UK-based British Lung Foundation early COPD [8] | • Pilot sample of 102 smokers at risk of developing clinical COPD (1000 aim to be recruited) | • Aged 30–45 years • > 10 pack-years smoking history • No/mild airflow limitation | No control population in this study | • Lung function testing • Chest CT | Unknown |