At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Double-blind Placebo-controlled Multicenter Clinical Trial of Bacterial Polyvalent Vaccine (BACTEK®), Administered Sublingually in COPD Patients, to Evaluate Efficacy, Safety, and Immunomodulatory Response.
In Brief
A Phase 3 clinical trial evaluating Placebo and MV130 for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 198 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
The participants will receive daily dose of placebo during 12 months sublingually.
The participants will receive daily dose of MV130 during 12 months sublingually.