Respiratory clinical trials routinely ask sites to manage three separate devices for spirometry, oscillometry, and fractional exhaled nitric oxide measurement, then reconcile the data afterward. Signant Health and Lothar Medical signed a letter of intent on September 5 to build a single commercialized offering that collapses that workflow, pairing Lothar’s portable ALDS PRO system with Signant’s TrialMax eCOA platform and its Ametris wearable technology. The practical consequence for sponsors: one device handles all three pulmonary assessments on-site, and the resulting data feeds directly into the same evidence stack capturing patient-reported outcomes and continuous movement measures.
The integration matters because the three measurements are complementary in ways that matter clinically. Spirometry captures forced-effort lung volumes; oscillometry measures airway mechanics during normal tidal breathing, which makes it useful in patients who cannot perform forced maneuvers reliably; and FeNO provides an objective signal tied to airway inflammation. Linking all three to eCOA data gives sponsors a direct connection between what patients report feeling and what the physiology shows, which is exactly the evidence picture regulators increasingly want in respiratory programs. Signant framed this as an extension of its Sensor-Enhanced eCOA strategy, which it accelerated when it acquired Ametris (formerly ActiGraph) in May 2026, adding validated wearable-derived endpoints to its eCOA portfolio.
The commercialization structure gives Signant exclusive rights to distribute ALDS PRO for drug trial applications. That exclusivity is significant: it means sponsors running respiratory programs through Signant would gain access to ALDS PRO as part of an integrated service rather than sourcing the device separately and solving the data integration problem themselves. Both companies are presenting at the European Respiratory Society International Congress in Barcelona this week, booth U.02B, where they are running live demonstrations of ALDS PRO alongside the Ametris ActiGraph LEAP wearable. The demos are framed explicitly as proofs of concept, not as a commercially available integrated product yet.
The letter of intent is a framework, not a signed contract, so the integration could still change in scope or timeline. The number to watch is how quickly the companies move from LOI to a formal agreement and regulatory-ready validation package, since sponsors evaluating respiratory programs in 2027 planning cycles will need that clarity before they can spec ALDS PRO into a protocol.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
