Clinical trial NCT01842360: Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Randomized Double-blind Placebo-controlled Prospective, Parallel, Multicentre Clinical Trial of Bacterial Vaccine Administered by Sublingual Mucosa in Subjects With COPD for Efficacy and Safety Evaluation and Immunomodulatory Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Vaccine
Chronic obstructive pulmonary disease (COPD)
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
First posted: 2013-04-29
Enrollment: 180
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV130 in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with a placebo group.

Detailed description: Double blind parallel placebo controlled study. The subjects will receive medication during 12 months and will be followed up during another six months

Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Both gender
* Age between 35 and 85.
* Must be able to follow the treatment regimen
* Diagnosis of moderate COPD according to GOLD criteria
* Consumption of 10 or more packs of cigarettes/year
* Fertile women of must use an approved contraceptive method

Exclusion Criteria:

* Pregnant women, breastfeeding
* Subject who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion
* Subject with severe COPD
* Subject with a history of hypersensitivity to any component of the vaccine
* Subject outside of age range
* Subject diagnosed with asthma
* Subject who has had an exacerbation 4 weeks before starting the trial.
* Subject that have needed corticosteroids in the last 4 weeks before starting the trial

  * Subject diagnosed with Primary or Secondary Immunodeficiency Subjects with chronic lymphoproliferative disease
  * Subjects with chronic infectious disease
  * Subject with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.
  * Subject diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa

Primary outcomes:
measure: Decrease in the number of COP exacerbations.
timeFrame: 18 months
Secondary outcomes:
measure: Severity of COPD exacerbations
timeFrame: 18 months
measure: First COPD exacerbation
timeFrame: 18 months
measure: Medication consumption
timeFrame: 18 months
measure: Health resource consumption
timeFrame: 18 months
measure: Number of visits to the emergency service
timeFrame: 18 months
measure: Number of hospitalizations due to COPD exacerbations
timeFrame: 18 months
measure: Changes from baseline in COPD Assessment Test (CAT)
timeFrame: 18 months
measure: Changes from baseline in immunological parameters
timeFrame: Baseline and 12 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 18 months
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Hospital Universitario de Vic
state: Barcelona
city: Torrejón de Ardoz
country: Spain
facility: Hospital de Torrejon
state: Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
name: Eduardo Fernández-Cruz, MD-PhD-prof
role: STUDY_DIRECTOR
name: Javier Miguel Díez, MD
role: PRINCIPAL_INVESTIGATOR
name: José Luis Alvarez-Salas, MD-PhD-prof,
role: PRINCIPAL_INVESTIGATOR
name: María Jesús Buendía, MD
role: PRINCIPAL_INVESTIGATOR
name: Carlos José Álvarez, MD
role: PRINCIPAL_INVESTIGATOR
name: Soledad Alonso, MD
role: PRINCIPAL_INVESTIGATOR
name: Francisco García, MD
role: PRINCIPAL_INVESTIGATOR
name: Joan Serra, MD
role: PRINCIPAL_INVESTIGATOR
References: