LUNG FUNCTION
• Yearly rate of decline in FEV
, FVC, and SVC prior to ipratropium and salbutamol
_.inhalation from day 1 until completion of the trial (30 days post study drug
_.treatment).
• Yearly rate of decline in FEV, FVC, and slow vital capacity (SVC) measured
_.90 minutes after inhalation of ipratropium (and 30 minutes after inhalation of
_.salbutamol) from day 1 until completion of the trial (30 days post study drug
_.treatment).
• Difference between treatment groups at each visit for estimated pre- and post-
_.bronchodilator FEV, FVC, and SVC from day 30 until the completion of double-
_.blind treatment.
• Yearly rate of decline in trough FVC and SVC from day 30 until completion of
_.double-blind treatment. Trough FVC and SVC are the pre dose values measured
_.approximately 24 hours after the previous dose of study drug.
• Yearly rate of decline in FVC and SVC measured 90 minutes after inhalation of
_.study drug and ipratropium (and 30 minutes after salbutamol) from day 30 until
_.completion of double-blind treatment.
HRQoL (HEALTH RELATED QUALITY OF LIFE)
• Yearly rate of decline in St. George's Respiratory Questionnaire (SGRQ) total,
_.impact, symptom, and activity scores from 6 months until completion of double-
_.blind treatment.
• Difference between treatment groups at each visit for estimated SGRQ total,
_.impact, symptom, and activity scores from 6 months until completion of double-
_.blind treatment.
EXACERBATION / HOSPITALISATION
Time to first COPD exacerbation and time to first COPD exacerbation leading to hospitalization.
• Number of COPD exacerbations
• Number of patients with at least one COPD exacerbation
• Number of COPD exacerbation days
• Number of patients with at least one COPD exacerbation leading to hospitalization
• Number of hospitalizations for COPD exacerbations
• Number of days hospitalized due to COPD exacerbations
• Time to first COPD exacerbation treated with steroids
• Number of COPD exacerbations treated with steroids
• Time to first COPD exacerbation treated with antibiotics
• Number of COPD exacerbations treated with antibiotics
SAFETY
• All adverse events
• All serious adverse events
MORTALITY
• All-cause mortality (On Treatment / Vital Status)
• Respiratory mortality
