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 prevalent, they are traditionally assessed through patient-reported outcomes (PROs). However, measuring improvement in cough and lung sounds objectively via wearables can still provide meaningful strategic and financial advantages to sponsors.
Novel Insights into Treatment Response
Continuous monitoring of cough and lung sounds does more than show changes in symptoms. It can provide a dynamic view of how a therapy works across time, dosing cycles, and real-world conditions.
One important advantage is the ability to evaluate diurnal variation. Respiratory symptoms often fluctuate throughout the day, with many patients experiencing worsening cough overnight or in the early morning. Continuous monitoring allows sponsors to quantify these patterns and determine whether a therapy meaningfully reduces nocturnal disruption or stabilizes day-to-day variability.
Quantifying reductions in nocturnal symptoms may also support differentiation in domains such as sleep disruption and early-morning symptom burden, areas that are meaningful to patients but under-measured by patient reported outcomes.
Monitoring cough and lung sounds also allows sponsors to better assess onset of treatment effect. By aligning symptom data with dosing schedules, it becomes possible to see how quickly a drug takes effect or whether the benefit lasts throughout the dosing interval. These insights can support dose optimization and strengthen confidence in pharmacodynamic response.
Measuring cough and lung sounds alongside other parameters also allows analysis of relationships between symptom burden, activity levels, or sleep disruption. If reductions in cough align with improved activity or fewer nighttime awakenings, it can reinforce the clinical meaningfulness of the data. This can strengthen the overall narrative around how a therapy impacts quality of life.
Differentiation in Competitive Markets
The respiratory development landscape is increasingly crowded, with multiple therapies targeting overlapping inflammatory and fibrotic pathways. In many programs, improvements in pulmonary function tests such as FEV1 cluster tightly across competing molecules. When efficacy curves overlap, sponsors need additional evidence streams to demonstrate meaningful differentiation. In this environment, objective cough and lung sound monitoring can provide a critical advantage by capturing ground truth data that traditional assessments such as PROs might miss. Unlike recall-based questionnaires, continuous acoustic monitoring captures every cough event and lung sound in real time, creating an objective physiologic record rather than a retrospective summary. When delivered through validated, chest-based continuous monitoring platforms, this data provides a level of precision and auditability suitable for inclusion in regulatory-grade clinical development programs.
Including objective cough and lung sound measures as a secondary or exploratory endpoint can help create a much stronger scientific case for your therapy. These additional data streams can support regulatory dialogue, investor communications, and lifecycle planning by providing a clearer picture of symptomatic impact beyond spirometry alone. Later, these data can also inform label expansion strategies or post-marketing studies, reinforcing a therapy’s differentiation.
Reducing Reliance on Patient Reported Outcomes (PROs)
Demonstrating improvement to quality of life and how patients feel and function remains essential to regulators, with PROs such the St George’s Respiratory Questionnaire and Visual Analog Scale (VAS) commonly used to assess changes in symptom burden.
While PROs are invaluable in reflecting patients’ lived experience, they can also introduce variability. Recall bias and placebo effects can complicate interpretation. In diseases characterized by coughing or wheezing, the way patients perceive their symptoms does not always match the actual physiological changes happening in their bodies. In cases where PRO improvements are modest or variable, objective data can say with certainty whether a physiologic response occurred or not.
When PRO results and sensor data match, it builds high confidence that the treatment is effective. Divergence between perceived symptoms and objective data can also generate valuable clinical insight. This can help sponsors refine the dosage or identify which specific types of patients benefit most. Ultimately, objective cough and lung sound monitoring isn’t here to replace the patient’s voice; it can add a layer of evidence that makes the entire story easier to interpret.
From Exploratory Endpoint to Strategic Asset
In many programs, objective cough and lung sound monitoring begins as an exploratory endpoint. Sponsors may initially include it to generate additional insight without increasing regulatory risk. Over time, however, these data streams can evolve in strategic importance. Objective symptom data may support trial enrichment by identifying highly symptomatic patients, improve dose selection decisions in Phase II, and strengthen the overall evidentiary package entering pivotal development.
As evidence accumulates across studies, what began as exploratory measurement can become a repeatable component of development strategy, informing regulatory discussions, label positioning, and lifecycle planning. In this way, objective cough and lung sound monitoring shifts from a supplemental metric to a strategic asset within the respiratory development program.
The Potential Financial Benefits and Return on Investment
Including cough monitoring and other digital endpoints in a clinical trial requires an upfront investment. For sponsors managing portfolios under strict capital discipline, the key question is whether that investment improves financial return.
Recent evidence suggests that it can, and the drivers are increasingly well understood.
A 2024 peer-reviewed financial modeling analysis evaluated the impact of incorporating digital endpoints on expected net present value (eNPV) and return on investment (ROI) in respiratory drug development. In Phase II trials, incorporating digital endpoints increased expected net present value by approximately $2.2 to $3.3 million per indication, with modeled returns ranging from 32% to 48%.
In Phase III, digital endpoints were associated with increases in eNPV of roughly $27 to $40 million, with modelled returns estimated at four to six times the original digital investment. These gains were driven primarily by improved probability of technical success, earlier signal detection, and optimized trial design assumptions.
Another study shows that using objective cough monitoring may require nearly half the patients compared to those using subjective questionnaires to achieve the same statistical power. This allows for smaller enrollment sizes and more accurate effect size estimation, significantly lowering the “per-patient” cost of the trial.
Objective cough and lung sound data may also enable more effective screening and recruitment of highly symptomatic patients, improving signal detection and overall trial efficiency.
Conclusion
Objective cough and lung sound monitoring is no longer limited to chronic cough trials. It is increasingly being incorporated into broader respiratory development programs because it offers value that extends beyond regulatory requirements.
The value is clear: it strengthens differentiation in competitive markets, complements PRO data with physiologic evidence, and improves clarity around treatment response. It enables a clearer interpretation of how a therapy works, who it works for, and how meaningfully it impacts patients’ daily lives.
At the same time, emerging financial analyses suggest that the benefits are not purely scientific. Improvements in signal detection, enrollment precision, and trial efficiency can translate into measurable return on investment.
As respiratory drug development becomes more competitive and capital allocation more disciplined, sponsors are looking for tools that enhance clarity, confidence, and long-term value. Objective cough and lung sound monitoring is increasingly viewed not as an optional add-on, but as a strategic component of modern respiratory trial design.
Author
Matthew McCarty
Matthew McCarty is Chief Commercial Officer at Strados Labs, where he leads sales, marketing, partnerships, and overall commercial strategy. He brings nearly 20 years of experience across life sciences and clinical trials, with deep expertise in respiratory endpoints and decentralized data collection, working closely with pharmaceutical sponsors, biotech companies, and CROs.