April 17, 2012 – ElectroCore LLC received conditional approval today from the US Food and Drug Administration to commence a pilot study of its AlphaCore® therapy for patients with exercise-induced bronchoconstriction (EIB).
AlphaCore therapy is a proprietary neuromodulation treatment that alters the brain’s control over the smooth muscle of the lungs to both treat asthma-like bronchoconstriction attacks, and may prevent the onset of such events.
This 60-patient, multi-center randomized pilot study will investigate the feasibility and safety of utilizing the AlphaCore therapy on patients for prevention or relief of acute bronchial hyper-responsiveness during exercise.
This study will be conducted in parallel with another similar study in COPD patients whose exacerbations can be triggered by exertion, which is being carried out at the Karolinska Institute in Sweden, home of the nominating committee for the Nobel prize in Medicine.
These studies are part of the company’s ongoing efforts to characterize the safety and effectiveness of the AlphaCore therapy in support of regulatory approvals in the United States, as well as to support clinical acceptance and payor reimbursement in the European Union and other regions of the world where the therapy is already commercially available.
The AlphaCore is CE marked for the treatment or prevention of symptoms of reactive airway disease, including asthma, bronchoconstriction, exercise induced bronchospasm, and COPD.
The study will be listed on ClinicalTrials.gov.