Takeaways from the ATS 2025 Innovation Hub Session: Tuning In To Cough In Pulmonary Fibrosis

by | Jun 3, 2025 | Blog - Clinical Trial Focus

At this year’s ATS conference, Strados Labs was proud to host the session, “Tuning In To Cough in Pulmonary Fibrosis: How Should We Address the Gap?” presented by Dr. Toby Maher, Professor of Clinical Medicine at the Keck School of Medicine, USC. The talk focused on cough in pulmonary fibrosis, a highly prevalent, debilitating symptom for ILD patients.

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In case you missed it, here are the key takeaways from the session.

Cough is a Highly Debilitating, Cardinal Symptom in Pulmonary Fibrosis

Cough in pulmonary fibrosis is not innocuous – it is one of the most frequent and burdensome symptoms reported by patients.1 It can be persistent and debilitating, leading to social withdrawal, sleep disruption, urinary incontinence, and reduced productivity.2 Cough frequency has also been shown to be higher in pulmonary fibrosis compared to other respiratory diseases such as COPD and asthma.3

There is an Unmet Therapeutic Need for Cough in Pulmonary Fibrosis

Current FDA-approved antifibrotic therapies show limited evidence for relieving cough.4 In clinical practice, physicians often turn to off-label treatments—opioids, neuromodulators, and inhaled anesthetics—which can pose challenges such as limited efficacy, tolerance development, and addiction risks.5 This highlights the urgent need for safe and effective interventions targeting cough in ILDs.

Cough Is an Outcome Measure That Reflects How Patients Feel and Function

At the 2023 NIH/FDA/Patients & Investigators Symposium on endpoints in IPF trials, a strong message emerged: outcomes that improve how patients feel and function should play an important role in clinical trials—not just those that extend survival.6 Cough burden consistently correlates with reduced quality of life, offering a meaningful, measurable, and patient-centered endpoint that could improve how we assess the therapeutic impact of treatments for pulmonary fibrosis.

Objective Cough Monitoring Can Enhance Our Insight into Cough Burden Alongside Patient-Reported Outcomes

Validated patient questionnaires such as the Visual Analog Scale (VAS), the Leicester Cough Questionnaire (LCQ) and the Living with Pulmonary Fibrosis Questionnaire (L-PF) are traditionally used to measure cough burden and are useful in capturing patients’ own perspectives on their cough. However, they have limitations such as recall error and are subjective, lacking the ‘ground truth’.

Digital health technologies allow for continuous, objective measurement of cough in patients’ daily lives, providing metrics such as cough frequency or intensity. These tools, in combination with PROs, can lead to a much greater understanding of treatment effects on patients’ cough burden.

Conclusion

Cough is a highly debilitating, burdensome symptom in pulmonary fibrosis with an unmet therapeutic need. As more importance continues to be placed on how patients feel and function, cough represents an endpoint that’s measurable and consistently correlates with daily impact. By measuring cough through a combination of PROs and objective technologies, sponsors can take a more comprehensive approach to treating ILDs.

Learn more about Strados Labs’ cough monitoring solution for your clinical trial or research study.

References

  1. Saunders P et al. The Burden and Impact of Cough in Patients with Idiopathic Pulmonary Fibrosis: An Analysis of the Prospective Observational PROFILE Study. Ann Am Thorac Soc. 2023 Sep;20(9):1267-1273. doi: 10.1513/AnnalsATS.202302-174OC. PMID: 37159951; PMCID: PMC10502892.
  2. Cox IA et al. Health-related quality of life of patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis. Eur Respir Rev. 2020 Nov 5;29(158):200154. doi: 10.1183/16000617.0154-2020. PMID: 33153990; PMCID: PMC9488638.
  3. van Manen et al. Cough in idiopathic pulmonary fibrosis. Eur Respir Rev. 2016 Sep;25(141):278-86. doi: 10.1183/16000617.0090-2015. PMID: 27581827; PMCID: PMC9487209.
  4. Wijsenbeek M et al. INBUILD Trial Investigators. Effects of nintedanib on symptoms in patients with progressive pulmonary fibrosis. Eur Respir J. 2024 Feb 1;63(2):2300752. doi: 10.1183/13993003.00752-2023. PMID: 38135442; PMCID: PMC10831140.
  5. Birring SS et al. Treatment of Interstitial Lung Disease Associated Cough: CHEST Guideline and Expert Panel Report. Chest. 2018 Oct;154(4):904-917. doi: 10.1016/j.chest.2018.06.038. Epub 2018 Jul 20. PMID: 30036496.
  6. Raghu G et al. Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on ‘Feels, Functions, Survives’. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency. Am J Respir Crit Care Med. 2024 Mar 15;209(6):647-669. doi: 10.1164/rccm.202312-2213SO. PMID: 38174955; PMCID: PMC12039048.