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

Laura Conejero Hall, Luis Puente Maestu, Myriam Calle Rubio, Walter Girón, Carlos José Alvarez Martínez, María Jesús Buendía García, Joan Serra Batllés, Juan Luis Rodríguez Hermosa, Soledad Alonso Viteri, Julia García De Pedro, Paola Benedetti, Javier De Miguel Díez, José Luis Alvarez-Sala Walther, Julio Hernández Vázquez, Francisco García Río, Carmen Rodríguez Sainz, Cristina Fernández Pérez, Ana Doyle, Raquel Caballero, José Luis Subiza, Miguel Casanovas, Eduardo Fernández-Cruz
European Respiratory Journal 2021 58: RCT207; DOI: 10.1183/13993003.congress-2021.RCT207
Laura Conejero Hall
1Inmunotek SL, Madrid, Spain
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  • For correspondence: lconejero@inmunotek.com
Luis Puente Maestu
2Pneumology Service, Hospital General Universitario Gregorio Marañon. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
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Myriam Calle Rubio
3Pulmonology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain
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Walter Girón
2Pneumology Service, Hospital General Universitario Gregorio Marañon. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
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Carlos José Alvarez Martínez
4Respiratory Medicine Department, Hospital Universitario 12 de Octubre, Madrid, Spain
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María Jesús Buendía García
5Pulmonology Department, Hospital Universitario Infanta Leonor, Madrid, Spain
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Joan Serra Batllés
6Pneumology Department, Hospital de Vic, Barcelona, Spain
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Juan Luis Rodríguez Hermosa
3Pulmonology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain
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Soledad Alonso Viteri
7Pneumology Department, Hospital Universitario de Torrejón, Madrid, Spain
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Julia García De Pedro
2Pneumology Service, Hospital General Universitario Gregorio Marañon. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
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Paola Benedetti
2Pneumology Service, Hospital General Universitario Gregorio Marañon. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
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Javier De Miguel Díez
2Pneumology Service, Hospital General Universitario Gregorio Marañon. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
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José Luis Alvarez-Sala Walther
3Pulmonology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain
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Julio Hernández Vázquez
5Pulmonology Department, Hospital Universitario Infanta Leonor, Madrid, Spain
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Francisco García Río
8Department of Pneumology, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain
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Carmen Rodríguez Sainz
9Clinical Immunology Service, Hospital Universitario Gregorio Marañon. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
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Cristina Fernández Pérez
10Servicio de Medicina Preventiva y Salud Pública, Complejo Hospitalario Universitario de Santiago de Compostela, La Coruña, Spain
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Ana Doyle
1Inmunotek SL, Madrid, Spain
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Raquel Caballero
1Inmunotek SL, Madrid, Spain
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José Luis Subiza
1Inmunotek SL, Madrid, Spain
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Miguel Casanovas
1Inmunotek SL, Madrid, Spain
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Eduardo Fernández-Cruz
9Clinical Immunology Service, Hospital Universitario Gregorio Marañon. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain
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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.

  • COPD - management
  • Immunology
  • Vaccination

Footnotes

Cite 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).

  • Copyright ©the authors 2021
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RCT Abstract - Randomized, double-blind, placebo-controlled, phase III clinical trial with MV130, a sublingual bacterial immunotherapy to prevent COPD exacerbations
Laura Conejero Hall, Luis Puente Maestu, Myriam Calle Rubio, Walter Girón, Carlos José Alvarez Martínez, María Jesús Buendía García, Joan Serra Batllés, Juan Luis Rodríguez Hermosa, Soledad Alonso Viteri, Julia García De Pedro, Paola Benedetti, Javier De Miguel Díez, José Luis Alvarez-Sala Walther, Julio Hernández Vázquez, Francisco García Río, Carmen Rodríguez Sainz, Cristina Fernández Pérez, Ana Doyle, Raquel Caballero, José Luis Subiza, Miguel Casanovas, Eduardo Fernández-Cruz
European Respiratory Journal Sep 2021, 58 (suppl 65) RCT207; DOI: 10.1183/13993003.congress-2021.RCT207

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RCT Abstract - Randomized, double-blind, placebo-controlled, phase III clinical trial with MV130, a sublingual bacterial immunotherapy to prevent COPD exacerbations
Laura Conejero Hall, Luis Puente Maestu, Myriam Calle Rubio, Walter Girón, Carlos José Alvarez Martínez, María Jesús Buendía García, Joan Serra Batllés, Juan Luis Rodríguez Hermosa, Soledad Alonso Viteri, Julia García De Pedro, Paola Benedetti, Javier De Miguel Díez, José Luis Alvarez-Sala Walther, Julio Hernández Vázquez, Francisco García Río, Carmen Rodríguez Sainz, Cristina Fernández Pérez, Ana Doyle, Raquel Caballero, José Luis Subiza, Miguel Casanovas, Eduardo Fernández-Cruz
European Respiratory Journal Sep 2021, 58 (suppl 65) RCT207; DOI: 10.1183/13993003.congress-2021.RCT207
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