Increased importance has been placed in recent years on the ability of idiopathic pulmonary fibrosis (IPF) treatments to impact how patients feel and function, beyond survival (Raghu, et al., 2024). In IPF, one of the most burdensome symptoms impacting how patients...
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...
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...
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...
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...
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...
