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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...
Unpacking the FDA Advisory Committee Meeting for Merck’s Gefapixant
In November 2023, Merck's chronic cough drug, gefapixant, faced a decisive setback from the FDA Advisory Committee. The concerns highlighted insufficient evidence for the drug providing a clinically meaningful benefit to adults with refractory chronic cough (RCC) or...
Beyond Cough Count: Why It’s Time to Go Deeper in Cough Trials
24-hour cough frequency has traditionally been recognized as the ‘gold standard’ primary endpoint for indications such as refractory chronic cough, chronic bronchitis, and IPF-related cough. While frequency is undoubtedly a valuable metric to measure for cough, there...
Navigating the FDA Digital Health Technology Guidance: Insights for Respiratory Drug Developers
In December 2023, the FDA published its final release of "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” a pivotal step in formalizing regulatory standards and guidance for remote data collection in clinical trials. As the FDA...
COPD Remote Patient Monitoring: Overview & New Technologies
Chronic obstructive pulmonary disease (COPD) affects many people globally, causing distress to patients and families and burdening healthcare systems. It is a challenging disease to manage. According to studies, COPD hospitalizes approximately 700,000 individuals in...
Cough and Wheeze Endpoint Measurement: Objective or Subjective?
Changes in symptoms such as coughing and/or wheezing are highly important endpoints in clinical trials focused on COPD, Asthma, IPF, Cystic Fibrosis, and other indications. With the growing availability of digital health technologies (DHTs) and wearables, it is now...
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