Evinova, the health-technology company within the AstraZeneca group, has formed a strategic partnership with Lothar Medical to integrate multi-function pulmonary testing directly into its global clinical-trial infrastructure. Under the agreement, Evinova’s Unified Trial Solution will connect with Lothar Medical respiratory devices capable of combining three measurements that are frequently collected separately: forced spirometry, airway oscillometry and fractional exhaled nitric oxide. Evinova says its GxP-validated trial platform is already deployed at more than 4,000 sites across 54 countries, giving the collaboration a potentially large route into asthma, COPD, bronchiectasis and interstitial lung disease studies.
This is not a drug approval or clinical efficacy result, but it addresses an important and underappreciated problem in pharmaceutical development. Respiratory trials can require patients to perform multiple physiological tests using different instruments, while sites must reconcile separate data streams, verify test quality and ensure measurements were obtained according to protocol. Evinova and Lothar Medical are attempting to consolidate more of that process into one connected system in which objective pulmonary measurements, patient-reported symptoms and other digital endpoints can be managed within the same trial environment.
Why do respiratory trials need more than ordinary spirometry?
Spirometry is the most familiar pulmonary-function test and measures how much air a patient can move and how quickly they can move it. FEV1, the amount exhaled during the first second of a forced maneuver, is one of the most widely used endpoints in asthma and COPD development.
But FEV1 does not describe every aspect of respiratory disease.
Airway oscillometry can measure respiratory-system resistance and reactance during normal tidal breathing, potentially providing information about small-airway abnormalities without requiring the forceful exhalation used in spirometry.
FeNO measures nitric oxide in exhaled air and can provide a biomarker of type 2 airway inflammation. It is particularly relevant in asthma, where biologic medicines increasingly target immunological subgroups rather than treating every patient as biologically identical.
A trial may therefore want spirometry for lung function, oscillometry for airway mechanics and FeNO for inflammation, plus symptom questionnaires and exacerbation tracking. Using separate devices multiplies setup, calibration, training and data-integration requirements.
Lothar Medical’s ALDS PRO architecture is intended to combine those objective assessments within one portable platform.
How could combining three tests actually make a clinical trial faster?
The first opportunity is patient screening. Respiratory studies often have strict eligibility requirements based on FEV1, bronchodilator response, inflammatory biomarkers or other physiological characteristics.
If each measurement requires a separate appointment, device or workflow, a candidate who eventually fails one criterion may consume substantial site time before being excluded.
Combining tests can potentially compress screening and make it easier to identify patients who genuinely meet the protocol.
The second opportunity is endpoint collection. Respiratory studies may require repeated measurements over months or years. Every additional instrument creates another opportunity for missed visits, incomplete data, calibration problems and protocol deviations.
The third is data cleaning. When outputs from multiple devices are entered into separate systems, study teams may spend substantial effort reconciling timestamps, patient identifiers and inconsistent results.
The Evinova integration is designed to move those measurements into a unified digital environment alongside patient-reported outcomes and other study data.
Whether this actually shortens trial timelines will need to be demonstrated prospectively. The partnership announcement describes the intended operational advantage, not a completed randomized comparison of trial execution.
What exactly is Evinova’s Unified Trial Solution?
Evinova is a separate health-technology business created within the AstraZeneca group to commercialize digital tools developed from pharmaceutical clinical-development experience.
Its Unified Trial Solution is designed to connect sponsors, sites and participants across traditional, hybrid and decentralized studies. Evinova says the platform is GxP validated and used by more than 4,000 sites across 54 countries.
The broader strategy is to reduce the number of disconnected digital tools used during a trial. Clinical sites frequently complain that every sponsor introduces different portals, logins and devices, creating administrative work unrelated to actually treating or evaluating patients.
A unified platform can potentially centralize scheduling, patient engagement, endpoint capture and monitoring.
Adding Lothar’s respiratory data directly into that architecture extends the model from software workflow into connected diagnostic hardware.
Why is FeNO becoming more important in respiratory drug development?
Respiratory medicine is moving increasingly toward phenotype- and biomarker-driven treatment. Two patients can both have asthma but have very different underlying inflammatory pathways, which means the same medicine may work dramatically in one and poorly in the other.
FeNO can provide information about type 2 airway inflammation and can complement blood eosinophils and clinical history when characterizing asthma biology.
For a drug trial, this can matter in two ways. Developers may use biomarkers to select the patients most likely to respond, or they may use changes in a biomarker to understand whether the medicine is affecting its intended pathway.
Integrating FeNO with spirometry creates a richer picture: one measurement describes inflammatory biology while another describes functional airflow.
Oscillometry adds yet another dimension by evaluating mechanical properties of the respiratory system.
This is why a three-in-one platform could be more than a convenience device. It could support increasingly multidimensional respiratory trial designs.
Why might oscillometry be easier for some patients than forced spirometry?
Spirometry requires patients to inhale deeply and then exhale forcefully and completely according to precise coaching. Quality depends heavily on effort and technique.
That can be difficult for children, frail adults, people with severe lung disease and patients who struggle to understand or physically execute the maneuver.
Oscillometry is generally performed during normal breathing. Small pressure oscillations are introduced into the airway, and the system measures how the respiratory tract responds.
Because it requires less forced effort, it can potentially generate useful information in populations where conventional spirometry is difficult.
This does not make oscillometry a universal replacement for spirometry. The measurements describe different physiological properties and clinical standards remain much more established for traditional spirometric endpoints in many drug programs.
The value of the Lothar platform is therefore combination rather than substitution.
What regulatory status does Lothar Medical’s technology have?
Lothar Medical says its respiratory solutions are CE-marked and registered as Class IIa devices with the U.K. MHRA, and the company operates under ISO 13485 quality-system certification.
Those claims relate to current international use and should not be converted into a statement that ALDS PRO is FDA cleared in the United States. The Business Wire announcement does not identify a U.S. 510(k) authorization for the integrated trial offering.
This distinction becomes particularly important in multinational clinical trials. A device may be suitable for research or clinical use in one jurisdiction while facing a different regulatory pathway elsewhere.
Sponsors also need to distinguish between measurements being used for exploratory research and those serving as pivotal endpoints supporting a regulatory drug application.
If a pulmonary-function measure becomes central to a drug’s efficacy claim, regulators will scrutinize device validation, calibration and data integrity closely.
What endpoints could flow through the combined Evinova-Lothar system?
Evinova identifies FEV1, peak expiratory flow, FeNO and symptom diaries among the types of primary or secondary information that can potentially be connected through the platform. Exploratory measurements can include large- and small-airway resistance and reactance obtained through oscillometry.
That combination is potentially useful because one patient visit can produce several layers of evidence.
A COPD therapy might improve airflow while also changing symptom burden. An asthma biologic might reduce type 2 inflammation before the full functional benefit becomes visible. An interstitial-lung-disease program may combine patient-reported limitations with objective physiological progression.
Bringing those observations onto one timeline can make it easier for researchers to understand how the disease and treatment are changing together.
The technical challenge is ensuring that integration does not alter the validated behavior of each component. Clinical-trial systems need audit trails, data security, version control and clear provenance showing exactly how and when each measurement was generated.
Why is AstraZeneca building clinical-development technology as a separate business?
Large pharmaceutical companies spend enormous amounts running clinical trials and consequently develop internal tools to solve their own operational problems. AstraZeneca launched Evinova as a separate health-tech business so that some of those capabilities could be offered more broadly across the pharmaceutical industry.
That positioning is strategically unusual because potential Evinova customers can also be AstraZeneca competitors. Evinova therefore has to operate as a credible independent technology provider despite remaining within the AstraZeneca group.
Its value proposition is that tools built inside an active global drug developer may reflect real operational problems more closely than generic enterprise software.
The Lothar partnership reinforces that thesis by connecting software to therapeutic-area-specific medical technology rather than attempting to build one generic platform for every endpoint.
Is this partnership the same as Signant Health’s agreement with Lothar Medical?
No, although both involve Lothar Medical’s respiratory technology and were announced around the same time.
Signant Health announced a letter of intent regarding a planned clinical-trial offering using ALDS PRO together with its eCOA and digital-endpoint capabilities. Evinova separately announced a strategic partnership to integrate Lothar respiratory devices with its Unified Trial Solution.
The proximity of the announcements is itself interesting. It suggests Lothar is pursuing multiple routes into pharmaceutical development rather than relying on one exclusive technology ecosystem.
For clinical-trial sponsors, interoperability can be valuable because different studies already use different eCOA, trial-management and endpoint vendors.
For Lothar, wider integration increases the number of trials in which its three-in-one pulmonary testing could potentially be used.
Could this genuinely improve patient experience?
Potentially, but that benefit needs evidence.
A participant in a respiratory trial may already be taking experimental medicine, attending frequent site visits, completing electronic diaries, wearing sensors and performing repeated lung tests. Reducing the number of devices and duplicate procedures can make participation less burdensome.
Simpler testing could also improve retention. Losing participants after months or years of follow-up is costly scientifically because missing data weaken statistical power.
Evinova says its broader digital approaches have demonstrated improvements in trial experience and efficiency in prior work, but those historical platform results should not be interpreted as proof that the new Lothar integration itself will produce the same effect.
The specific collaboration needs its own operational data showing whether sites complete assessments faster, patients make fewer errors and sponsors receive cleaner datasets.
Why might this matter commercially to pharmaceutical companies?
Clinical development is expensive partly because delays compound. A protocol amendment, slow recruitment or repeated data-cleaning problem can push a program back months, extending the period before a potentially valuable medicine reaches the market.
If integrated diagnostics help identify eligible patients faster, reduce site burden and generate more complete endpoint data, the financial impact can be larger than the price of the device itself.
Respiratory trials are especially suitable because objective lung measurements are central to many development programs and often have highly standardized procedural requirements.
The economic test will be whether one integrated system reduces enough equipment, site time, training and data reconciliation to justify switching from established vendors and workflows.
What should pharma sponsors watch next?
The most valuable next evidence would come from actual trials using the integrated platform.
Sponsors need to know whether the three-in-one device reduces screening time, how frequently tests must be repeated for quality reasons and whether data agree with conventional reference systems across geographically diverse sites.
They will also want to understand interoperability with existing electronic data-capture, eCOA and trial-management infrastructure.
Regulatory acceptance will be another major issue if measurements are used as pivotal endpoints rather than exploratory data.
The partnership nevertheless reflects a broader shift in clinical development. The industry is moving away from thinking about a trial as a series of isolated tests uploaded into separate databases. The emerging model treats patients, devices, symptoms and physiological measurements as one connected data stream.
Lothar Medical is trying to compress three respiratory instruments into one portable device. Evinova is trying to compress the surrounding digital trial infrastructure into one platform. Whether that combination measurably accelerates drug development remains to be proven, but the operational problem they are attacking is very real.
