How Can Monitoring Cough & Lung Sounds Add Value in Respiratory Clinical Trials?

While regulators may not require objective cough and/or lung sound monitoring outside of chronic cough studies, sponsors increasingly recognize that relying solely on pulmonary function tests and patient-reported outcomes leaves critical insight on the table. In conditions such as pulmonary fibrosis, bronchiectasis, COPD, and asthma where cough and lung sounds such as wheezing are highly […]

From Stethoscope to Sensor: How We Developed a Lung Acoustics Wearable

The advent of wearable technology is changing how we monitor health across a range of conditions, offering continuous, real-world insights into patients’ vitals and physiological data. At Strados Labs, our goal was to develop a wearable specifically for monitoring patients with chronic respiratory diseases such as COPD and asthma. Our approach? Model our technology after […]

Cough Counting Approaches Explained: Which One Is Best?

Cough monitoring, namely for the measurement of cough frequency, has seen increased interest and use in clinical trials to provide a greater understanding of treatment effects on subjects’ cough. As sponsors and researchers evaluate cough monitoring technologies for their studies, an important aspect to consider is the cough counting method used to determine cough frequency.   […]

Regulatory Pathways for Cough Monitoring in Clinical Trials: FDA Validation Requirements Explained

Cough monitoring has emerged as an increasingly common practice in research studies and drug development in recent years to objectively measure changes in subjects’ cough. As drug developers consider including cough frequency as an endpoint in their studies, understanding the current regulatory pathway and the FDA’s validation requirements is essential. To support trial sponsors, we’ve […]

Leicester Cough Questionnaire: An Overview

The Leicester Cough Questionnaire (LCQ)1 is a self-reporting tool developed by S.S. Birring and others to evaluate the impact of chronic cough on a patient’s quality of life. Chronic cough,2 which impacts between 10-20% of the US population,3 is a cough that can last up to 8 weeks or longer. It can be both a […]