Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study

Bellerophon Therapeutics launched a Phase 2b clinical trial with the goal of developing treatments for cardiopulmonary diseases. For this study, the biotherapeutics company deployed traditional Clinical Outcome Assessments (COAs), oxygen saturation (SpO2) and 6 Minute Walk Distance (6MWD), as primary endpoints. However, the evidence collected wasn’t statistically significant or strong enough to proceed to a Phase 3 clinical trial.

Fortunately, as part of the clinical study design, the sponsor included ActiGraph’s wearable data collection solution to evaluate possible changes in study participants’ Physical Activity (PA) including, but not limited to, the change in Moderate to Vigorous Physical Activity (MVPA) from baseline, as an exploratory endpoint.

Discover how the use of Actigraph’s objective, continuous digital outcome measures saved Bellerophon Therapeutics’ clinical development program.