A Study in People With Pulmonary Fibrosis to Monitor Cough With a Wearable Device

A Multi-center, Longitudinal 12-week Pilot Study to Evaluate Cough Severity and Its Impact, Utilizing a Next Generation Cough Monitor, in Participants With Idiopathic Pulmonary Fibrosis (IPF) or Non IPF Pulmonary Fibrosis

This study is open to adults aged 18 years and older who have pulmonary fibrosis with or without a known cause (or other forms of pulmonary fibrosis).

The purpose of this study is to better understand coughing in people with pulmonary fibrosis. To do this, a wearable cough monitor called Strados Remote Electronic Stethoscope Platform (RESP) is used. This device will measure how often and how forceful coughing is in people with pulmonary fibrosis.

All participants in the study get the device. It is placed on their skin over the chest.

Participants are in the study for 3 months. During this time, they visit the study site 2 to 3 times. 4 visits are done at the participant's home by video call with the site staff.

During the study, the device measures coughing over 24 hours. This is done on 4 days. Participants fill in questionnaires about their coughing and doctors regularly check participant's lung function. A breathing test that measures how well the lungs are working is performed both in the office and during home visits. The doctors also regularly check participants' health and take note of any unwanted effects.

This study will also record patients' experiences using the cough monitor and video assisted breathing tests at visits 3, 4, 5 and 6 at home.

Study Overview

• Status: Completed
• Conditions: Pulmonary Fibrosis
• Intervention / Treatment: Device: A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Aalst - HOSP Onze-Lieve-Vrouw
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis - Campus Virga Jesse
  • Kortrijk, Belgium, 8500
    • Kortrijk - HOSP AZ Groeninge Kennedylaan
  • Roeselare, Belgium, 8800
    • Roeselare - HOSP AZ Delta
• Germany
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Jena, Germany, 07747
    • Universitätsklinikum Jena
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Hospital
  • Breda, Netherlands, 4818 CK
    • Amphia ziekenhuis
  • Rotterdam, Netherlands, 3015 CP
    • Erasmus Medisch Centrum
• United States
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Critical Care, Pulmonary and Sleep Associates
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Lung and Critical Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• Provision of signed informed consent in writing prior to study data collection
• Subject aged 18 years or over
• Subject diagnosed with Non-Idiopathic Pulmonary Fibrosis (IPF) Pulmonary Fibrosis (>10% fibrosis on High Resolution Computed Tomography (HRCT) by principal investigator assessment) or IPF as per American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Asociación Latinoamericana de Tórax (ATS/ERS/JRS/ALAT) Guidelines within the past 12 months
• Forced Vital Capacity (FVC) > 40% predicted at baseline visit
• Life expectancy > 6 months (per assessment of treating physician)

Exclusion criteria

• Current smokers
• Upper Respiratory Tract Infection (URI) or Lower Respiratory Tract Infection (LRTI, including Coronavirus Disease (COVID)-19 infection) within 4 weeks of screening visit
• Airflow obstruction (Forced expiratory volume in one second (FEV1)/FVC < 70%) at baseline or known history of significant spirometry response to bronchodilator
• Cough due to etiology other than Interstitial Lung Disease (ILD) (e.g., allergic rhinitis, Gastroesophageal Reflux Disease (GERD))
• Other respiratory disorders including, but not limited to, a current diagnosis of any obstructive disease including chronic obstructive pulmonary disease (COPD) and asthma, active tuberculosis, lung cancer in treatment or in medical history, sleep apnea, known alpha-1 antitrypsin deficiency, cor pulmonale, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary diseases.
• Initiation or change in dose or type of anti-tussive medication, angiotensin-converting enzyme (ACE) inhibitors, opiates, and systemic or inhaled (excluding intranasal) corticosteroids in the 4 weeks prior to study entry
• Subject with ILD exacerbation as defined by investigators within 4 weeks prior to study entry
• Subject participating in a clinical study of a systemic or inhaled drug at the time of enrollment
• further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with IPF or non IPF pulmonary fibrosis; Participants with IPF or non IPF pulmonary fibrosis.	Device: A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection; A wearable cough monitoring device, the Strados Labs Remote Electronic Stethoscope Platform (RESP)ᵀᴹ sensor, with an accompanying mobile application (App) for data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82	Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4, Week 8, and at Day 82.	At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82	Change from baseline (CfB) in cough count per hour (CC/h) at Week 4, Week 8 and at Day 82. Cough count per hour (CC/h) was measured over a 24-h period.	At baseline (Visit 2), Week 4, (Visit 4) Week 8 (Visit 5) and at Day 82 (Visit 6).
Forced Vital Capacity (FVC) at Baseline and at Week 12	Forced Vital Capacity (FVC) at baseline and at Week 12.	At baseline (Visit 2) and at Week 12 (Visit 7).
Change From Baseline in Forced Vital Capacity (FVC) at Week 12	Change from baseline in Forced Vital Capacity (FVC) at Week 12.	At baseline (Visit 2) and at Week 12 (Visit 7).
Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture)	Feasibility of remote cough data capture , defined as % of analysable cough device data per 24-hours recording. The percentage of analysable data per 24-hours recording period was derived from cough count (CC) recording times (total readable recording time) and defined as: (Total readable recording time/24 hours)·100 Percent of analysable cough data is percentage of 24 hours of total expected recording time that was readable.	At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).
Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design)	Successful completion of all elements of remote visit (feasibility of hybrid study design). Successful completion of a remote visit was based on the questions on the home trial procedures: Was home spirometry performed?; Was the video conference tele-visit completed?; Was the 24-hour cough recording completed? The number (percentage) of participants who completed each element is reported by visit.	At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): March 7, 2024

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Fibrosis
• Other Study ID Numbers: 1490-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No