Clario and Strados Labs partner to bring new pulmonary endpoints to respiratory clinical trials

Clario has partnered with Strados Labs to offer its customers the RESP™ Biosensor System, an advanced technological innovation for the at-home capture of lung sounds. The revolutionary device enables Clario to support the capture of additional clinical respiratory endpoints such as cough and wheeze, and it does so in a patient-friendly, streamlined way. 

• High-quality information about cough can be particularly difficult to assess as patient self-reporting is highly subjective and existing solutions are burdensome for both patients and researchers. 
• The RESP Biosensor is the only FDA-cleared pulmonary wearable device for use at home that allows researchers to objectively capture a variety of lung sounds such as cough, wheeze, rhonchi and crackles.
• The Strados™ RESP Biosensor is a wireless, lightweight and patient-friendly device that records pulmonary sounds for 24 hours continuously without using bulky devices. Once recorded, patient data is transferred wirelessly via a provided mobile device for review by clinicians.

PHILADELPHIA, PA – March 21, 2023 – Clario, a healthcare research technology company that delivers leading endpoint technology solutions for clinical trials, today announced a partnership with Strados Labs to provide the FDA-cleared RESP Biosensor for clinical trials. This innovative, wearable device is lightweight, comfortable and non-invasive, with capabilities that have not previously existed on the market, such as allowing for objective assessment of crackles, rhonchi, and wheeze events, as well as offering a streamlined approach for at-home cough monitoring in trial participants.

The Strados RESP Biosensor is a refreshingly modern, patient-centered solution for Clario’s customers looking at additional respiratory data endpoints. The wireless device records pulmonary sounds for 24 uninterrupted hours and has the capacity to hold up to 220 hours (about one and a half weeks) of recordings on board. With the capabilities of a digital stethoscope, this device can capture lung sounds, enabling measurement of cough frequency, cough severity, cough type (e.g., dry, productive), and other adventitious events (e.g., wheeze, rhonchi, crackles).

“Clario has helped many sponsors to obtain high quality data supporting numerous drug approvals in respiratory clinical trials, and some of our customers are increasingly looking for robust and objective cough metrics – an endpoint that Strados Labs’ RESP Biosensor addresses fantastically. The RESP Biosensor’s capabilities eliminate the need for subjective self-reporting and introduce several new respiratory endpoints enabling sponsors to now demonstrate drug efficacy from different angles, enabling greater flexibility in protocol design while reducing the burden for clinical sites and patients.” Achim Schülke, Chief Innovation Officer at Clario.

The RESP Biosensor’s design reduces the burden placed on the patient in the at-home environment. Weighing only as much as a pen and less than half an inch thick, patients can discreetly wear the device on their chest under their clothes and carry on with their day as they ordinarily would. The device is wireless and rechargeable, so there is no need for messy cables or battery replacements.

After 24 hours of continuous recording, the patient docks the RESP Biosensor on the charger, and while it charges, the recorded audio is transferred to the Strados Clinician Portal for review via the Clario-supplied mobile device. This efficient data collection not only eliminates the need for patients to return to sites in person, but also allows clinicians to see patient data much sooner and make faster decisions, whether for patient screening or to support subjects in a study.

“Our goal is to provide clinical trials with much stronger respiratory data, allowing researchers to access lung sounds to determine when patients are coughing or wheezing, differentiate between cough type, and understand how symptoms progress over time in relation to medication use and other factors.” Said Nick Delmonico, CEO and Cofounder at Strados Labs. “We are extremely excited about this partnership with Clario and the potential to improve cough monitoring for many sponsors.”

For more information and a list of Strados Labs’ RESP Biosensor capabilities, please visit Clario’s Cough and Lung Sounds page.

About Clario

Clario is a leading healthcare research and technology company that generates the richest clinical evidence in the industry for our pharmaceutical, biotech and medical device partners. Across decentralized, hybrid and site-based trials, our deep scientific expertise, global scale and the broadest endpoint technology platform in the industry allows our partners to transform lives. Clario has the only technology platform that combines eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Clario’s global team of science, technology and operational experts have helped deliver over 24,000 trials and contributed to over 500 FDA and EMEA new drug approvals involving more than five million patients in 120 countries. Our innovation has been transforming clinical trials for 50 years.

For more information, visit Clario.com or follow us on LinkedIn and Twitter.

About Strados Labs

Strados Labs is a medical technology company focused on improving the lives of patients with respiratory disease through innovative technology. Enabling real-world monitoring of lung health, Strados Labs’ RESP Biosensor is a wearable device that allows clinicians to remotely detect changes in patient symptoms such as cough and wheeze that can indicate worsening health. The technology is used to assist clinical trials in the development of new therapies and to support healthcare teams in better managing patients with COPD, Asthma, and other cardiopulmonary diseases. The RESP Biosensor is FDA-cleared, CE marked and HIPAA compliant, backed by multiple awards and clinical publications. Strados Labs is privately owned and based in Philadelphia, PA.

For more information, visit Stradoslabs.com or follow us on LinkedIn and Twitter.