Evinova, a clinical development technology company within the AstraZeneca group, has agreed to a partnership with Lothar Medical to execute respiratory device clinical trials worldwide.
Under the deal, Evinova’s Unified Trial Solution will be integrated with Lothar Medical’s respiratory devices, with the aim of providing sponsors, trial sites and patients a more connected flow of data.
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The Unified Trial Solution is a G×P-validated platform used across traditional, hybrid and decentralised clinical trials, and is currently deployed at more than 4,000 sites in 54 countries.
Lothar Medical develops portable pulmonary function monitoring devices that combine three measurements, notably FeNO, oscillometry, and spirometry, in a single unit, allowing lung function testing in real time in both research and care settings.
The combination could assist teams running protocols in conditions such as asthma, bronchiectasis, chronic obstructive pulmonary disease and interstitial lung disease.
Respiratory conditions are often diagnosed late, and trial recruitment can prove difficult when real-world diagnosis does not match study entry criteria.
Using one device for screening and diagnosis may help identify eligible participants more quickly, according to the partners.
The integration is expected to support capture of primary and secondary endpoints, including FEV1, PEF, FeNO and symptom diaries, alongside exploratory measures such as large and small airway resistance and reactance.
A three-in-one device could cut the number of separate devices and workflows required at sites, while digital coaching and automated validation checks within the interface are intended to encourage correct use and improve data quality.
Evinova chief medical officer Tim Harrison said: “The partnership between Lothar Medical and Evinova represents an exciting step forward for respiratory clinical research.
“By combining innovative respiratory diagnostics with cutting-edge digital trial capabilities, we have the opportunity to redefine how respiratory studies are delivered and accelerate the development of more personalised care for patients.”
Lothar Medical’s products include the ALDS Ambulatory Lung Health System and ALDS PRO. Its devices are CE-marked, MHRA Class IIa registered, and ISO 13485 certified, and are used internationally by clinicians and research teams.
