A pooled data of patient baseline factors from GALATHEA and TERRANOVA Phase 3 trials have been analysed, to identify COPD patients who can benefit from benralizumab. Baseline efficacy factors; history of frequent exacerbations, lesser post-BD FEV1, greater post-BD FEV1 response and prior triple inhaled therapy use, in patients with baseline eosinophils ≥220 cells/µL, were associated with greater efficacy with benralizumab 100mg versus placebo. The greatest response was associated with prior triple inhaled therapy use, baseline blood eosinophils ≥220 cells/µL and ≥3 exacerbations within the last year. An ongoing Phase III trial will evaluate benralizumab efficacy in these patients.
An interesting lecture presented the RheOX® System for Bronchial Rheoplasty®. A non-thermal pulsed electric procedure that reduces abnormal mucus-producing cells, while leaving the extracellular matrix intact. Preclinical studies demonstrated epithelial ablation followed by rapid regeneration of normalised epithelium. Results were presented from a prospective, multi-centre study, enrolling 32 patients who underwent BR under general anaesthesia. The procedure was successfully performed in all patients with 2 serious adverse events related to the device.
A multicentre randomised clinical trial has been performed with 134 patients with severe COPD, to investigate if pulmonary tele-rehabilitation (PTR) has long-term superiority to conventional PR on walking capacity (primary outcome) and symptoms, quality of life, physical activity level, mortality and hospitalisations. The results showed no statistical differences in long term (12 months) outcomes between groups in PTR and PR.
The fourth late breaking abstract was related to a randomised, double-blind, placebo-controlled, cross-over, multi-centre study which evaluated the efficacy and safety of S-600918 (a P2X3 receptor-selective antagonist) in patients with refractory chronic cough. The 31 patients enrolled received either 150mg S-600918 or matched placebo for 2 weeks and after a washout phase of 2 to 3 weeks, the patients underwent the alternative treatment arm. Daytime coughs (primary endpoint) were reduced by 31.6% (no significance) and 24-hour coughs (secondary endpoint), was reduced by 30.9%. The overall incidence of treatment-emergent adverse events (AEs) was not significant.
Bronchoscopic lung volume reduction (BLVR) with the Zephyr® Valve improves function, exercise tolerance and quality of life (QoL) in hyperventilated severe emphysema patients. A post hoc analysis of patient-reported outcomes (PROs) has been conducted to determine the impact of the Zephyr® Valves on daily symptom burden and QoL. The results of this analysis show that Zephyr® Valves significantly improves dyspnoea and QoL, which is consistent with the results of the primary paper. Zephyr® Valves, however, do not impact cough and sputum production of chronic bronchitis, reinforcing its role in the treatment of emphysema.
From the ERS Madrid 2019 congress. Session ALERT: Abstracts leading to evolution in respiratory medicine trials: COPD and cough