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

Last updated: February 19, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

N/A

Condition

Lung Injury

Cystic Fibrosis

Scar Tissue

Treatment

A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection

Clinical Study ID

NCT05670587
1490-0005
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 53
Treatment Group(s): 1
Primary Treatment: A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection
Phase:
Study Start date:
January 16, 2023
Estimated Completion Date:
March 07, 2024

Connect with a study center

  • Aalst - HOSP Onze-Lieve-Vrouw

    Aalst, 9300
    Belgium

    Site Not Available

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500
    Belgium

    Site Not Available

  • Kortrijk - HOSP AZ Groeninge Kennedylaan

    Kortrijk, 8500
    Belgium

    Site Not Available

  • Roeselare - HOSP AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, 07747
    Germany

    Site Not Available

  • Rijnstate Hospital

    Arnhem, 6815 AD
    Netherlands

    Site Not Available

  • Amphia Ziekenhuis

    Breda, 4818 CK
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CP
    Netherlands

    Site Not Available

  • Critical Care, Pulmonary and Sleep Associates

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10021
    United States

    Site Not Available

  • Southeastern Research Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina 29406
    United States

    Site Not Available

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