The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies

Table 1 Clinical outcome measure responder definitions

Outcome	Responder definition^b	Reference
Daily respiratory symptoms^a
RS-Total score	≥2-unit decrease from baseline	[11]
RS-Breathlessness domain score	≥1-unit decrease from baseline
RS-Cough & Sputum domain score	≥0.7-unit decrease from baseline
RS-Chest Symptoms domain score	≥0.7-unit decrease from baseline
Health status
SGRQ total score	≥4-unit decrease from baseline	[19]
Dyspnea
TDI focal score	≥1-unit increase from baseline	[20]
Lung function
Trough FEV₁ (spirometry)	≥100 mL increase from baseline	[21]

^aHigher scores indicate more severe symptoms
^bPatients with a decrease from baseline that exceeded the pre-defined value were considered to have an improvement (responders). Patients with an increase from baseline that exceeded the pre-defined value were considered to have a worsening. Patients with a change from baseline in either direction that did not reach the pre-defined value were considered to have no change
FEV ₁, forced expiratory volume in 1 s; SGRQ, St George’s Respiratory Questionnaire; TDI, transition dyspnea index

ISSN: 1465-993X