Koneksa, a healthcare technology company developing evidence-based validated digital biomarkers, announces the launch of a clinical study comparing the treatment effect between at-home mobile spirometry using digital biomarkers and in-clinic spirometry in patients with moderate asthma on long-acting beta-agonist (LABA) treatment.
The LEARN study is a single arm interventional trial comparing the detection of treatment effects by means of at-home mobile spirometry using an ultrasonic spirometer and a smartphone, compared to in-clinic spirometry in participants with moderate asthma. The study will recruit up to 60 participants with moderate uncontrolled asthma over a 6-week treatment period who are taking inhaled corticosteroids (ICS) at the time of study enrollment but will require LABA therapy.
In-clinic spirometry can be done at-home with equal or better accuracy compared to in-clinic and potentially less burden to the patient. The study will evaluate the LABA treatment effect in clinic and mobile spirometry, and assess the relationship between different readouts of mobile spirometry in addition to assessing asthma control as measured by ACQ-6, a patient reported outcome questionnaire. Additional objectives include an evaluation of patient and site-specific satisfaction with mobile spirometry technology.
“This study builds on Koneksa’s prior work demonstrating that mobile spirometry has the potential to detect clinically meaningful changes in very small cohorts of asthma patients on standard of care,” said Chris Benko, CEO & Founder, Koneksa. “The LEARN study will evaluate whether at-home mobile spirometry can detect treatment effects of a known positive control (LABA) in a significantly smaller population than would traditionally be assumed for an in-clinic proof-of-concept study.”
“More frequent at-home mobile spirometry measurements 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,” said Dr. John A. Wagner, Chief Medical Officer, Koneksa. “We look forward to providing updates from the LEARN study, to 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.”
[Source(s): Koneksa, Business Wire]