Variables | |
---|---|
Demography and medical history | Age (years) Sex Race Ethnicity Body mass index (kg/m2) Pneumococcal vaccination status (baseline) Influenza vaccination status (baseline) |
COPD and exacerbation history | Duration of COPD, bronchitis/emphysema, moderate and severe exacerbation variables at baseline, smoking status/history Outcome data: mean annual moderate/severe exacerbation data to reproduce primary end point modelling |
Concomitant medication assessment | Medications at run-in/prior medications (including ATC codes and flags to identify prior period if needed) |
Outcome/efficacy assessments | Annual rate of moderate/severe COPD exacerbations as defined in the two clinical trials. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; severe: worsening symptoms of COPD that required treatment with in-patient hospitalisation |
Screening and baseline spirometry | Pre-bronchodilator FEV1 (L) Post-bronchodilator FEV1 (L) Per cent predicted post-bronchodilator FEV1 (%) Post-bronchodilator FEV1/FVC (%) Per cent reversibility FEV1 (%) FEV1 reversibility (mL) Reversibility at screening Baseline FEV1 (L) |
Physical examination | Screening/baseline medical conditions page: (body system level yes/no) with exception of cardiac disorders where each condition is listed explicitly from screening/baseline medical conditions page:
|
Laboratory assessments/ECG | Baseline lymphocytes, WBC, eosinophils, neutrophils, BUN/urea, RBC, haemoglobin, ECG (p-wave dispersion) |
ATC, anatomical therapeutic chemical; BUN, blood urea nitrogen; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; RBC, red blood cells; WBC, white blood cell counts.