Cough as an Endpoint in IPF: Why it Matters

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Idiopathic Pulmonary Fibrosis (IPF)

Objectively Monitor Cough and Crackles in Patients with IPF

Cough in IPF is a highly prevalent and burdensome symptom for patients, among the top symptoms rated by patients that impact their quality of life1. Cough has also been linked to disease survival and trajectory in multiple studies[JD1] 2,3,4

While FEV and FVC1 continue to be the primary way of measuring disease progression in IPF patients, more emphasis from regulators continues to be placed on measuring how patients feel, function and survive5. Cough monitoring in IPF has emerged as a promising outcome measure that can reveal direct, objective insight into patients’ lived experiences and offer drug developers a consistent and reliable endpoint. 

Additionally, velcro crackles are a common, hallmark symptom in patients with IPF6. While velcro crackles are typically observed for diagnostic purposes in early stages, studies have hinted that crackles might have a relationship to disease severity.7

Accurately measure cough and crackles in IPF patients from anywhere, anytime

The RESP® Biosensor offers clinicians and researchers an objective way to measure symptoms like cough and crackles associated with IPF.
  • Clinically validated accuracy, with equivalent performance to Littman 3200 stethoscope.
  • Continuous monitoring of cough and lung sounds to offer quantitative data on respiratory symptoms over time.
  • Patient-friendly, reduces the burden on patients while improving clinician efficiency.
Certifications: FDA 510(k) clearance, CE Mark, HIPAA Compliant
Strados Cough Monitoring Solution

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Objective monitoring detects more patients with coughs than patient self-reporting

For Healthcare

Improve surveillance of IPF patients with real-time monitoring of symptoms

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For Research Studies

Gain greater, objective insight into IPF treatment response in clinical trials

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Validated Overread and Event Annotation Process

Strados RESP biosensor data
  • We offer the gold standard approach for measuring cough – manual cough counting – with our team of respiratory therapists agreeing on hourly counts to meet regulatory and clinical requirements.
  • Machine learning algorithms* have been trained based on validated cough and lung sound events and performance tested to meet customer requirements.
  • Algorithms* allow for compression of cough recordings for manual overread or can be used independently for subject screening and other applications.

**Machine learning algorithms not FDA-cleared

Visual spectrograms of lung sound events facilitate overread for trained specialists

Cough

Wheeze

Crackles

Clinical Validation

Explore our peer reviewed performance testing, studies and publications.

Stepwise Validation Program for Cough Detection Algorithm to Monitor Chronic Cough

Objective Cough Monitoring Detects More Patients with Cough Than Patient Self-Reporting
Results of Clinical Performance Testing in Chronic Lung Diseases
View All Publications

What data does the device collect in IPF patients?

The RESP® Biosensor sits on the patient’s chest wall and passively records  patient’s lung sounds including cough, wheeze and crackles. The device also collects motion data to capture respiratory rate*, heart rate*, activity levels*, and body positioning*.

*Measurement not FDA-cleared

How do you know that the RESP® Biosensor is accurate?

The RESP Biosensor has received two FDA 510(k) clearances to record lung sounds. In order to receive FDA clearance,  Strados Labs provided test results that demonstrated audio performance that is substantially equivalent to commercially available electronic stethoscopes.

How is the device adhered to patients’ chests? Does it cause any discomfort?

The non-invasive RESP® Biosensor is placed over the skin and adhered via Tegaderm–acrylic based adhesive. Patients often forget the device is on when wearing and can go on with their daily routines.

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References

  1. Lee et al. (2022). Cough-Specific Quality of Life Predicts Disease Progression Among Patients With Interstitial Lung Disease: Data From the Pulmonary Fibrosis Foundation Patient Registry. Chest, 162(3), 603–613. https://doi.org/10.1016/j.chest.2022.03.025
  2. Cox, I. A., Borchers Arriagada, N., de Graaff, B., Corte, T. J., Glaspole, I., Lartey, S., Walters, E. H., & Palmer, A. J. (2020). Health-related quality of life of patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis. European respiratory review : an official journal of the European Respiratory Society, 29(158), 200154. https://doi.org/10.1183/16000617.0154-2020
  3. Wu et al. (2024). Cough Severity Visual Analog Scale Assesses Cough Burden and Predicts Survival in Idiopathic Pulmonary Fibrosis. American journal of respiratory and critical care medicine, 209(9), 1165–1167. https://doi.org/10.1164/rccm.202311-2169LE
  4. Wijsenbeek, et al. (2023). Home monitoring in interstitial lung diseases. The Lancet. Respiratory medicine, 11(1), 97–110. https://doi.org/10.1016/S2213-2600(22)00228-4
  5. Raghu et al. (2024). Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on ‘Feels, Functions, Survives’. American journal of respiratory and critical care medicine. 209. 10.1164/rccm.202312-2213SO; Wijsenbeek, et al. (2023). Home monitoring in interstitial lung diseases. The Lancet. Respiratory medicine, 11(1), 97–110. https://doi.org/10.1016/S2213-2600(22)00228-4
  6. Moran-Mendoza, O., Ritchie, T., & Aldhaheri, S. (2021). Fine crackles on chest auscultation in the early diagnosis of idiopathic pulmonary fibrosis: a prospective cohort study. BMJ open respiratory research, 8(1), e000815. https://doi.org/10.1136/bmjresp-2020-000815
  7. Sgalla, G., Walsh, S. L. F., Sverzellati, N., Fletcher, S., Cerri, S., Dimitrov, B., Nikolic, D., Barney, A., Pancaldi, F., Larcher, L., Luppi, F., Jones, M. G., Davies, D., & Richeldi, L. (2018). “Velcro-type” crackles predict specific radiologic features of fibrotic interstitial lung disease. BMC pulmonary medicine, 18(1), 103. https://doi.org/10.1186/s12890-018-0670-0