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

NCT05670587 | Completed Results FDA Device

• 1 other identifier: 1490-0005
• Study Type: interventional
• Target: 53
• Locations: 4 countries
• Sites: 13

Brief 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.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at 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).

• 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

  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)

  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)

  At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).

Study Arms (1)

Participants with IPF or non IPF pulmonary fibrosis

EXPERIMENTAL

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

Interventions

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

A wearable cough monitoring device, the Strados Labs Remote Electronic Stethoscope Platform (RESP)ᵀᴹ sensor, with an accompanying mobile application (App) for data collection.

Participants with IPF or non IPF pulmonary fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (13)

Critical Care, Pulmonary and Sleep Associates

Lakewood, Colorado, 80228, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

Lowcountry Lung and Critical Care

Charleston, South Carolina, 29406, United States

Location

Aalst - HOSP Onze-Lieve-Vrouw

Aalst, 9300, Belgium

Location

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium

Location

Kortrijk - HOSP AZ Groeninge Kennedylaan

Kortrijk, 8500, Belgium

Location

Roeselare - HOSP AZ Delta

Roeselare, 8800, Belgium

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

Location

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CP, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 4, 2023
• Study Start: January 16, 2023
• Primary Completion: February 22, 2024
• Study Completion: March 7, 2024
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); BE (4); DE (2); NL (3)