Calverley PMA, et al. – The target of this trial was to assess the efficacy and safety/tolerability of MEDI8968 in adults with symptomatic, moderate–to–very severe chronic obstructive pulmonary disease (COPD). The authors concluded that MEDI8968 did not produce statistically significant improvements in acute exacerbations of COPD (AECOPD) rate, lung function or quality of life in this phase II study.

Methods

• It was a phase II, randomised, double-blind, placebo-controlled, multicentre, parallel-group study.
• For this study, subjects aged 45–75 years and receiving standard maintenance therapy with ≥2 exacerbations in the previous year were randomised 1:1 to receive placebo or MEDI8968 300 mg (600 mg intravenous loading dose) subcutaneously every 4 weeks, for 52 weeks.
• The moderate/severe acute exacerbations of COPD (AECOPD) rate (week 56 post-randomisation) was the primary endpoint.
• Severe AECOPD rate and St George’s Respiratory Questionnaire-COPD (SGRQ-C) score (week 56 post-randomisation) were the secondary endpoints.

Results

• According to the findings obtained, of subjects randomised to placebo (n = 164) and MEDI8968 (n = 160), 79.3% and 75.0%, respectively, finished the investigation.
• Findings revealed that there were neither statistically significant differences between treatment groups in moderate/severe AECOPD rate ([90% confidence interval]: 0.78 [0.63, 0.96], placebo; 0.71 [0.57, 0.90], MEDI8968), nor in severe AECOPD rate or SGRQ-C scores.
• Post-hoc analysis of subject subgroups (by baseline neutrophil count or tertiles of circulating neutrophil counts) did not alter the examination result.
• It was noted that the incidence of treatment-emergent adverse events (TEAEs) with placebo and MEDI8968 treatment was similar.
• Data reported that the most common TEAE was worsening of COPD.