Source: International Congress 2016 – Monitoring airway diseases with clinical tools
Disease area: Airway diseases

Abstract

Background: Measuring change in symptoms of COPD is challenging in early studies assessing efficacy of new molecules. The new Evaluating Respiratory Symptoms in COPD (E-RS) tool provides total and 3 symptom subscale scores (breathlessness, cough and sputum, chest symptoms). We analyzed its potential to support early go/no go decisions in a Phase II clinical trial. Methods: E-RS scores from a planned 6 month interim analysis of a first-time-in-patient randomized clinical trial (NCT02130193, GSK Study 200163) were analyzed. This study evaluates 52 weeks treatment with danirixin, an oral CXCR2 antagonist when added to standard of care inhaled therapies in mild to moderate COPD subjects at risk for COPD exacerbations with respiratory symptoms. Results: Differences in E-RS total and subscale scores were observed between danirixin and standard of care groups beginning at 2 months and maintained through the 6 month interim period (Figure). The differences met or exceeded the proposed minimally important difference of -2 points through 6 months of treatment. Conclusions: E-RS demonstrated treatment associated differences in symptoms and supported continuation of the study. Differentiation between treatment groups was observed early after study start. These results highlight the potential of E-RS as a drug development tool for COPD assessing the impact of intervention in early clinical development. The study was sponsored by GSK.






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Bruce Miller (Phoenixville, United States of America), Bruce Miller, Ruth Tal-Singer, Aili Lazaar, Nancy Leidy, Henrik Watz, David Collins, John Yonchuk, Maggie Tabberer. Assessing symptoms in COPD: Use of the E-RS daily digital diary in early drug development. Eur Respir J 2016; 48: Suppl. 60, 1047

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