3 results
The primary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal…
Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.
Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device…