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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05670587
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Germany, Netherlands, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Fibrosis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: All participants

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lakewood, Colorado

Status

Recruiting

Address

Critical Care, Pulmonary and Sleep Associates

Lakewood, Colorado, 80228

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Renown Regional Medical Center, Reno, Nevada

Status

Recruiting

Address

Renown Regional Medical Center

Reno, Nevada, 89502

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Lenox Hill Hospital, New York, New York

Status

Recruiting

Address

Lenox Hill Hospital

New York, New York, 10021

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Southeastern Research Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Southeastern Research Center

Winston-Salem, North Carolina, 27103

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

Lowcountry Lung and Critical Care, Charleston, South Carolina

Status

Recruiting

Address

Lowcountry Lung and Critical Care

Charleston, South Carolina, 29406

Site Contact

Boehringer Ingelheim

unitedstates@bitrialsupport.com

833-602-2368

International Sites

Aalst - HOSP Onze-Lieve-Vrouw, Aalst, Belgium

Status

Recruiting

Address

Aalst - HOSP Onze-Lieve-Vrouw

Aalst, , 9300

Site Contact

Boehringer Ingelheim

belgique@bitrialsupport.com

080049616

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, Belgium

Status

Recruiting

Address

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, , 3500

Site Contact

Boehringer Ingelheim

belgique@bitrialsupport.com

080049616

Kortrijk - HOSP AZ Groeninge Kennedylaan, Kortrijk, Belgium

Status

Recruiting

Address

Kortrijk - HOSP AZ Groeninge Kennedylaan

Kortrijk, , 8500

Site Contact

Boehringer Ingelheim

belgique@bitrialsupport.com

080049616

Roeselare - HOSP AZ Delta, Roeselare, Belgium

Status

Recruiting

Address

Roeselare - HOSP AZ Delta

Roeselare, , 8800

Site Contact

Boehringer Ingelheim

belgique@bitrialsupport.com

080049616

Universitätsklinikum Freiburg, Freiburg, Germany

Status

Recruiting

Address

Universitätsklinikum Freiburg

Freiburg, , 79106

Site Contact

Boehringer Ingelheim

deutschland@bitrialsupport.com

08007234742

Universitätsklinikum Jena, Jena, Germany

Status

Recruiting

Address

Universitätsklinikum Jena

Jena, , 07747

Site Contact

Boehringer Ingelheim

deutschland@bitrialsupport.com

08007234742

Rijnstate Hospital, Arnhem, Netherlands

Status

Recruiting

Address

Rijnstate Hospital

Arnhem, , 6815 AD

Site Contact

Boehringer Ingelheim

nederland@bitrialsupport.com

08000204613

Amphia Ziekenhuis, Breda, Netherlands

Status

Recruiting

Address

Amphia Ziekenhuis

Breda, , 4818 CK

Site Contact

Boehringer Ingelheim

nederland@bitrialsupport.com

08000204613

Erasmus Medisch Centrum, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus Medisch Centrum

Rotterdam, , 3015 CP

Site Contact

Boehringer Ingelheim

nederland@bitrialsupport.com

08000204613

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