Roche’s Firefish clinical trial will evaluate drug efficacy against respiratory muscle function and breathing patterns in infants treated for SMA.
Orange County, CA, January, 2017 – Vivonoetics Inc., developer of VivoSense® respiratory testing solutions, announced today that in partnership with Great Lakes NeuroTechnologies, they will be providing advanced respiratory assessment to the Roche FIREFISH study.
Infants with Spinal muscular atrophy (SMA) develop respiratory insufficiency due to progressive respiratory muscle weakness caused by degeneration of alpha motor neurons in the spinal cord. This weakness results in ineffective airway clearance which is the major cause of morbidity and mortality in infants with SMA. Thus measurement of longitudinal changes in respiratory muscle function in infants and young children with SMA-1 is critical to the evaluation of interventions targeting SMA-1. Many studies of infants with SMA-1 are significantly hampered by the lack of appropriate respiratory testing tools, suitable for infant use. This results in many SMA-1 trials not appropriately evaluating objective measures of respiratory function.
Accurate measurement of pulmonary ventilation or breathing traditionally requires the use of devices such as masks or mouthpieces coupled to the airway opening. These devices are ill-suited for infant monitoring. As an alternative, the FIREFISH study will be the first large SMA-1 clinical trial to use Respiratory Inductance Plethysmography (RP) systems to non-invasively sense respiratory excursions of the body. By measuring and analyzing the precise patterns of movement of both the chest and abdominal wall, objective measures of pulmonary function may be appropriately evaluated. Specialty analysis of RP data for the evaluation of infant breathing is possible using Vivonoetics’ proprietary VivoSense® analysis software together with trained data analysts. Vivonoetics are the leading experts in providing analysis of RP for clinical trials. The VivoSense® analysis is expected to observe clinically significant changes in respiratory morbidity and mortality. “We strive to advance clinical trials through the use of wearable technology,” says Dudley Tabakin, Vivonoetics Chief Operations Officer. “With our expertise in wearable respiratory sensors and detailed data analytics we have developed a solution that works for monitoring infants with airway obstruction observed in SMA.”
RP sensing technology will be provided using the BioRadio from Great Lakes NeuroTechnologies, a wireless, wearable data acquisition system capable of recording RP on infants in real time. RP data are wirelessly transmitted to a computer via Bluetooth and made available to the Vivonoetics analytics team for post-collection processing and analysis. “Great Lakes NeuroTech is very proud to collaborate with Vivonoetics on this exciting study in SMA. This represents successful integration of wearable technology and advanced data analytics to capture infant respiration”, says Carissa Simmerman, BioRadio Clinical Trials Manager at Great Lakes NeuroTech. “We are strongly committed to using wearable and remote monitoring technology to make a positive impact on quality of life for those affected by respiratory disorders.”