Table 2.
Clinical event or parameter | Measure |
---|---|
Inadequate response to initial treatment | CAT score improvement <2 following intervention70,71 Insufficient symptomatic relief perceived by patient or physician1 • Changes in breathlessness • Changes in ability to carry out activities • Sleep quality • Are improvements worthwhile to patient? |
Increased use of rescue medication | Sustained, increased requirement for short-acting bronchodilators • Eg, ≥6 inhalations/day of salbutamol72 |
Hospitalization | Any single hospitalization related to COPD or its complications |
Worsening of symptoms | Worsening of COPD symptoms on clinical evaluation; deterioration in symptom or health-status assessment scores over time |
Suboptimal symptom control across the whole day | Problematic nighttime, early morning, and/or daytime COPD symptoms |
Suboptimal COPD control | Patient not achieving individualized treatment objectives in areas relating to COPD impact and stability: • CAT/CCQ scores • Degree of dyspnea • Use of rescue medication • Level of physical activity • Sputum color over time |
Exacerbation events | Occurrence of an exacerbation (or hospitalization) after maintenance-treatment initiation |
Reduction in lung function (in combination with other measures of clinical worsening) | Reduced FEV1 accompanied by an increase in disease severity, symptoms, or exacerbation rate, a decrease in exercise tolerance, or COPD comorbidities |
Abbreviations: CAT, COPD Assessment Test; CCQ, Clinical COPD Questionnaire; FEV1, forced expiratory volume in 1 second.