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Table 1 Clinical outcome measure responder definitions

From: 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

Outcome Responder definitionb Reference
Daily respiratory symptomsa
 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]
  1. aHigher scores indicate more severe symptoms
  2. 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
  3. FEV 1 , forced expiratory volume in 1 s; SGRQ, St George’s Respiratory Questionnaire; TDI, transition dyspnea index