RCT Abstract - Randomized, double-blind, placebo-controlled, phase III clinical trial with MV130, a sublingual bacterial immunotherapy to prevent COPD exacerbations

Abstract

Background: COPD exacerbations are associated with airway inflammation leading to increased patient morbidity and mortality. Respiratory tract infections due to viruses and/or bacteria are considered common triggers of COPD exacerbations. Sublingual mucosal bacterial immunotherapy (MV130) has been used to reduce infections in various clinical settings.

Aims: To evaluate the efficacy and safety of MV130, a whole cell inactivated polybacterial preparation, in the prevention of COPD exacerbations.

Methods: A randomized, double-blind, placebo-controlled, phase III clinical trial (EudraCT: 2012-003253-28) in a cohort of 198 subjects diagnosed with moderate to severe COPD was conducted in the Department of Pneumology of 7 hospitals in Spain. Subjects were allocated in a 1:1 ratio to receive sublingual MV130 or placebo for 12 months. The primary outcome was the number of COPD exacerbations during the 18 months of the study (12 of treatment plus 6 of follow-up) in MV130 group vs placebo. Secondary outcomes included duration of exacerbations, medication, and healthcare resources.

Results: The median of COPD exacerbations was 3.0 [interquartile range, IQR, 1.0-5.0] for placebo vs 2.0 [IQR, 1.0-3.0] in MV130 (P<0.01). The median duration in days of exacerbations (20.0 [IQR, 7.5-47.0] vs 10.0 [IQR, 5.0-24.0]) and total days of antibiotic consumption (29.0 [IQR, 5.0-63.5] vs 12.0 [IQR, 0.0-31.5]) were also lower in MV130 group (P<0.01). Only 2 subjects reported adverse reactions (both non-serious), one per arm.

Conclusions: MV130 reduces the number and severity of exacerbations in COPD patients as well as medication use with excellent safety profile.