In recent years, clinical trial respiratory technology advancements have revolutionized how to monitor and assess treatment efficacy for respiratory conditions. To delve deeper into these innovations, I had the opportunity to interview Nick Delmonico, the Founder, and CEO of Strados Labs, a pioneering company in this field. In our conversation, Nick shed light on the current state of objective cough and wheeze monitoring, its challenges, and the promising future of these technologies in enhancing clinical trials and patient care.
Moe: How common is it for clinical trial sponsors to objectively monitor cough and wheeze, and for which indications are this practice most prevalent?
Nick Delmonico: While objective cough and wheeze monitoring can offer unprecedented insight into treatment response, it has not yet seen widespread adoption in respiratory trials. The most common way sponsors currently measure improvement in symptoms like cough and wheezing has been through patient questionnaires/ePRO, which studies have shown can be more than 50% inaccurate compared to an objective, clinical patient assessment. Some technologies have been introduced for cough assessment, but they cannot measure what matters most to patients, which is how those symptoms impact their quality of life.
In specific indications such as chronic cough, the primary endpoint required by the FDA is to reduce 24-hour cough frequency using an objective cough monitor. New clinical trial respiratory technology that makes monitoring cough and lung sounds less cumbersome will likely lead to greater use in chronic respiratory disease indications such as COPD, idiopathic pulmonary fibrosis (IPF), and asthma.
Moe: What differentiates advanced clinical trial respiratory technologies from traditional monitoring methods?
Nick Delmonico: One of the main advantages of newer clinical trial respiratory technology is their ease of use and lower burden placed on patients/subjects. Traditionally, cough monitors have been bulky with wires that make it hard for subjects to act normally in their daily routines while potentially skewing cough results based on the sense of being monitored (known as the Hawthorne effect). Newer clinical trial respiratory technology is much more discreet and make it easier for subjects to forget they’re being watched.
Another advantage of newer clinical trial respiratory technology is their ability to collect more data points. Traditional technologies have focused on cough frequency, while newer technologies allow researchers to measure cough intensity, coughing bouts, and lung sounds such as wheezing and crackles. Other measurements such as respiratory rate, activity levels, and sleep/wake can provide further context about the impact of cough on quality of life.
Moe: How can sponsors monitor lung sounds like wheezing and crackles to add value to clinical trials?
Nick Delmonico: While cough is where sponsors typically start when considering an objective technology, we can now also capture adventitious lung sounds that can provide even more significant clinical context. For example, wheezing is a hallmark symptom in asthma that can reveal airway obstruction; crackles are especially common in idiopathic pulmonary fibrosis (IPF) and congestive heart failure (CHF), indicating fluid in the lungs. While questionnaires like the Asthma Control Test typically ask about these symptoms, we are excited by the possibility for sponsors to measure it objectively alongside cough.
Moe: Will objective cough monitoring replace self-reporting, or will it complement it?
Nick Delmonico: We see objective cough monitoring complementing patient self-reports and not replacing them. Ultimately, patients are the best judge of how they’re feeling. However, it is too difficult for patients to remember their symptoms in detail, when they occurred, and how much exactly. Cough monitoring can fill this gap and provide objective ground truth to anchor patient self-reports; likewise, patient self-reports can offer meaningful context to numbers and metrics collected by wearables. Both patient self-reporting and objective data are valuable and provide the most complete information and compelling evidence when used together.
Moe: Where has advanced respiratory monitoring technology been used, and what challenges have been encountered in clinical trials?
Nick Delmonico: Newer respiratory monitoring technologies have started to replace traditional cough monitors in collecting the primary endpoint (24-hour cough frequency) in chronic cough studies. They are also beginning to be used to measure exploratory endpoints in studies such as COPD and asthma, where objective measurement of symptom improvement isn’t required. Still, sponsors are recognizing its value in demonstrating their drug’s effectiveness.
No matter how seamless the technology is, deploying a wearable device in a clinical trial always presents challenges: figuring out the global supply chain and what to do when subjects don’t follow protocol or have wifi/cell service in their house.
Moe: What is the future of cough and wheeze monitoring over the next decade?
Nick Delmonico: Symptoms like coughing and wheezing are predominantly seen as an indication of quality of life. This is an exciting time where cough and wheeze frequency have the potential to transition towards a biomarker for disease severity. When spirometry was developed 175 years ago, it was not recognized as the gold standard in measuring lung health like today. Increased coughing and wheezing have long been shown to correlate with disease severity or precede exacerbations; now that it’s easier to measure this objectively, we suspect that more studies will confirm this is the case and make cough and wheeze monitoring more widespread.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
