MedTrace Logo

Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)

NCT01842360 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-10-02

Study results available
· View outcomes & findings →

Summary

The goal of this clinical trial is to learn whether the bacterial vaccine MV130 helps reduce the number of exacerbations in adults with moderate to severe COPD. It will also assess the safety and immune effects of MV130. The main questions it aims to answer is: Does MV130 lower the number and severity of COPD flare-ups? Other questions include: Does it reduce the use of healthcare resources and improve quality of life?

Researchers will compare MV130 to a placebo (a similar spray without the active substance; bacterial species) to see how well it works. Participants will use either MV130 or placebo daily under the tongue for 12 months, attend regular clinic visits, and be followed for an additional 6 months to monitor health outcomes and side effects.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

BIOLOGICAL

Placebo

The participants will receive daily dose of placebo during 12 months sublingually.

BIOLOGICAL

MV130

The participants will receive daily dose of MV130 during 12 months sublingually.

Sponsors & Collaborators

  • Inmunotek S.L.

    lead INDUSTRY

Principal Investigators

  • Eduardo Fernández Cruz, MD, PhD · Hospital General Universitario Gregorio Marañón

  • Javier de Miguel Díez, MD, PhD · Hospital General Universitario Gregorio Marañón

  • José Luis Álvarez-Sala, MD, PhD · Hospital San Carlos, Madrid

  • María J Buendía, MD · Hospital Universitario Infanta Leonor

  • Carlos J Álvarez, MD, PhD · Hospital Universitario 12 de Octubre

  • Soledad Alonso, MD · Hospital Universitario de Torrejón,Madrid

  • Francisco García, MD, PhD · Hospital Universitario La Paz

  • Joan Serra, MD · Hospital de Universitario Vic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-06
Primary Completion
2019-07-29
Completion
2023-08-02

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01842360 on ClinicalTrials.gov