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.
This was a randomized, double-blind, placebo-controlled, prospective, parallel, multicenter clinical trial designed to evaluate the efficacy, safety, and immunomodulatory effects of a sublingually administered bacterial polyvalent vaccine (BACTEK®, also known as MV130) in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study was conducted by Inmunotek, S.L., and included seven sHospitals across Spain. A total of 198 participants were enrolled and randomized equally into two groups to receive either MV130 or placebo over a period of 12 months, followed by a 6-month observation phase, totaling 18 months of participation per participant. The investigational product, MV130, consisted of a glycerinated suspension containing six inactivated non-lysate bacterial species: Streptococcus pneumoniae, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae. The product was administered sublingually at a dosage of two sprays (0.2 mL total) per day. The placebo formulation was identical in appearance and composition, excluding the active bacterial components. All study participants received their first dose under supervision at the clinical site and were trained for home administration. Eligible participants were between 35 and 85 years old, with a diagnosis of moderate or severe COPD according to GOLD guidelines, a history of recurrent exacerbations (≥3 moderate or ≥2 with at least one hospitalization in the past year), and a smoking history of at least 10 pack-years. Subjects were excluded if they had very severe COPD, a history of recent exacerbations or systemic corticosteroid use, concurrent immunodeficiency or serious comorbid conditions, or if they were pregnant, breastfeeding, or unwilling to use contraception during the study. The primary efficacy endpoint was the total number of COPD exacerbations during the full 18-month period. Secondary endpoints included the severity of exacerbations, time to first exacerbation, healthcare resource usage (hospitalizations, emergency room visits, unscheduled consultations), medication use, health-related quality of life (assessed using the CAT questionnaire), and a pharmacoeconomic evaluation based on healthcare expenditures. In a subset of participants, immunological parameters were also assessed to explore the immunomodulatory response. Safety analysis included all randomized participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
198
Hospital Universitario de Vic
Vic, Barcelona, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Number of COPD Exacerbations.
Comparison in the number of COPD exacerbations in the two study groups in the 18-month study period.
Time frame: 18 months
Change in the Rate of COPD Exacerbations.
Incidence is the number of new events per total participants in the sample population.
Time frame: 18 months
Change in Severity of COPD Exacerbations.
The severity of exacerbations was to be measured by the consumption of health care resources: Emergency Department/Hospitalisation/Intensive Care Unit/Consultations visits, as follows: ICU hospitalisation 4 points Hospitalisation 3 points Emergency room visit 2 points Consultation resulting in change in usual treatment 1 point
Time frame: 18 months
Time Elapsed Between Start of Treatment and First COPD Exacerbation.
For reference, median survival or event-free times are reported with the 95% CI of the median.
Time frame: 18 months
Use of Drugs (Antibiotics, Corticosteroids, Etc).
The use of drugs will be calculated using the following index: * antibiotics: 1 point * inhaled corticosteroids: 2 points * systemic corticosteroids: 3 points
Time frame: 18 months
Number of Hospitalizations Due to a COPD Exacerbation.
The same patient could have more than one hospitalizations.
Time frame: 18 months
Days of Hospitalization Due to a COPD Exacerbation.
Number of days of hospitalization per patient were recorded. The same patient could have more than one hospitalization.
Time frame: 18 months
Number of Visits to the Emergency Room.
Number of individual visits were recorded per patient. One patient could have multiple visits.
Time frame: 18 months
Number of Unscheduled Medical Consultations Due to COPD
Number of consultations per patient. One patient could have multiple consultations.
Time frame: 18 months.
Health Related Quality of Life.
COPD Assessment Test per patient determined by an adapted version of the specific COPD Assessment Test. Minimum value is 0 (better) and maximum value is 40 (worse). The change between two or more time points is reported. Change between baseline and 18 months in shown.
Time frame: 18 months
Healthcare Resource Utilization During COPD Exacerbations
Healthcare resource utilization was assessed as the sum of: * Complementary tests * Programmed visits to the specialist * Total number of visits to the specialist * Non-programmed visits to the specialist * ICU hospitalization days * Visits to the emergency room * Days hospitalized * Sum of antibiotics * Number of visits to General Practitioner * Sum of oral corticosteroids * Number of telephone calls to the GP * Sum of inhalers * Home visits * Sum of antipyretics Total number of healthcare resources used during COPD exacerbation episodes. Data were summarized per treatment group and reported as total counts and percent differences. No baseline or monetary data were collected
Time frame: 18 months
Adverse Events and Overall Tolerability (Adverse Reactions).
Total number of adverse events in Active (MV130) and Placebo groups were compared.
Time frame: 18 months
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