Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)
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.
Timeline
- Start
- 2013-05-06
- Primary completion
- 2019-07-29
- Completion
- 2023-08-02
Outcome
Met primary endpoint
registry MEDIAN Active - MV130: 2.0 (1.0 to 3.0) number of exacerbations NCT01842360 ↗
registry analysis (superiority test); Active - MV130 vs Placebo; p <0.01; Wilcoxon (Mann-Whitney) NCT01842360 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MV130 | Vaccine | 0.2 ml | Other |