RT Journal Article
SR Electronic
T1 RCT Abstract - Randomized, double-blind, placebo-controlled, phase III clinical trial with MV130, a sublingual bacterial immunotherapy to prevent COPD exacerbations
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP RCT207
DO 10.1183/13993003.congress-2021.RCT207
VO 58
IS suppl 65
A1 Laura Conejero Hall
A1 Luis Puente Maestu
A1 Myriam Calle Rubio
A1 Walter Girón
A1 Carlos José Alvarez Martínez
A1 María Jesús Buendía García
A1 Joan Serra Batllés
A1 Juan Luis Rodríguez Hermosa
A1 Soledad Alonso Viteri
A1 Julia García De Pedro
A1 Paola Benedetti
A1 Javier De Miguel Díez
A1 José Luis Alvarez-Sala Walther
A1 Julio Hernández Vázquez
A1 Francisco García Río
A1 Carmen Rodríguez Sainz
A1 Cristina Fernández Pérez
A1 Ana Doyle
A1 Raquel Caballero
A1 José Luis Subiza
A1 Miguel Casanovas
A1 Eduardo Fernández-Cruz
YR 2021
UL http://erj.ersjournals.com/content/58/suppl_65/RCT207.abstract
AB 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.FootnotesCite this article as: European Respiratory Journal 2021; 58: Suppl. 65, RCT207.This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).