Dic 17, 2015
Results of a multicentre, double-blind, randomised, controlled, phase IV study in Chronic Obstructive Pulmonary Disease(COPD) patients were recently published1: the AIACE study (Advanced Immunological Approach in COPD Exacerbation). The study, which involved two hundred eighty-eight patients with moderate to very severe COPD, was carried out between July 2009 and July 2013, including a three years enrolment period. This study showed benefits of PMBL™ as add-on therapy to COPD patients, for example by significantly increasing the time between exacerbations, and significantly reducing by over two-fold the number of days of hospitalisation, an important criteria in terms of pharmacoeconomics.
The AIACE study, which was developed according to criteria of evidence-based medicine, evaluated whether the administration of PMBL™ sublingual tablets to COPD patients, in addition to the recommended treatment, was able to reduce the number of exacerbations by 25%. This primary end-point could not be statistically achieved. However, the authors reported that secondary end-points results demonstrated potential benefits of PMBL. Several clinical outcomes were significantly improved with the treatment: the number of days with fever (21 days per year for PMBL group versus 40.15 for placebo; p < 0.001), the days of hospitalisation (65 days for PMBL group vs 162 days for placebo; p < 0.001), the interval between first and second exacerbations (123.89 days for PMBL group vs 70.36 for placebo; p < 0.03) and the number of days in poor health (109 days/year for PMBL group vs. 171 days/year for placebo; p < 0.001). These outcomes are interesting both from the patient perspective and on pharmacoeconomics terms: almost 100 days of hospitalization could be saved over the 12 months study.