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Trial to Assess At-Home Asthma Lung Function Tests

Adult inhaler user

(NIAID, Flickr. https://flic.kr/p/LyQUUT)

17 Jan. 2023. A clinical trial is set to begin that compares monitoring of lung functions in people with asthma using portable ultrasound and mobile app at home to conventional tests in a clinic. The trial is conducted by digital health technology company Koneksa in New York evaluating spirometry, a common technique for testing lung capacity, for monitoring patients’ asthma treatments at home.

Koneksa is a seven year-old company that develops software for measuring biomarkers or health indicators from digital data, particularly for clinical trials in partnerships with drug makers. Among the company’s lead products is a system for measuring lung function data with a portable ultrasound spirometer device and app designed for the iPhone. A spirometer measures a person’s lung capacity, specifically amount of air forced from the lungs in one second, called forced expiratory volume in one second or FEV1. This measure is considered the gold standard of lung function measurements and in most cases require patients to visit a clinic for spirometry tests.

In the Koneksa respiratory system, data from the portable spirometer are sent via Bluetooth to a mobile iPhone app that forwards the data to the cloud for analysis with algorithms. Koneska says the system can be used to assess FEV1 in patients with other respiratory diseases, such as Covid-19 and COPD, as well as asthma. The company is partnering with biopharmaceutical company Regeneron, a developer of monoclonal antibody treatments for Covid-19, on validating remote FEV1 measurements.

Testing LABA with inhaled corticosteroids

Patients receiving treatment for chronic asthma need to visit their physician or clinic periodically for a spirometer test to assess their progress. Koneska says its system is designed to conduct the test a home, enabling more frequent tests of lung function, as well as reduced time and cost to the patient. In Oct. 2020 a Koneska team published results of a pilot test with asthma patients that found a high correlation between FEV1 measurements of patients using an at-home spirometer and conventional spirometry in a clinic.

The new clinical trial, says Koneska, is evaluating the remote spirometry system among patients with moderate asthma taking inhaled corticosteroids, supplemented with long-acting beta-agonist or LABA therapy. LABA treatments are used only when inhaled corticosteroids are not sufficient to relax tightened muscles in the airways, and need close monitoring due to safety concerns. The study is not yet listed on ClinicalTrials.gov, the U.S. government registry.

Koneska says the the ability of its remote spirometry system to capture data more frequently makes it possible to enroll a smaller number of patients than usual in the trial. “More frequent at-home mobile spirometry measurements,” says Koneska chief medical officer John Wagner in a company statement released through BusinessWire, “are expected to be more sensitive and accurate and may provide earlier detection of treatment effect in a smaller sample size when compared with in-clinic spirometry.” Wagner adds the study will “evaluate whether digital biomarkers derived from remote monitoring with a smart device and mobile spirometer can provide additional information correlated to symptom scores in asthma.”

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