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

Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05670587
• Other study ID #: 1490-0005
• Status: Completed
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: March 7, 2024

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 7, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
Belgium	Aalst - HOSP Onze-Lieve-Vrouw	Aalst
Belgium	Jessa Ziekenhuis - Campus Virga Jesse	Hasselt
Belgium	Kortrijk - HOSP AZ Groeninge Kennedylaan	Kortrijk
Belgium	Roeselare - HOSP AZ Delta	Roeselare
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Universitätsklinikum Jena	Jena
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Erasmus Medisch Centrum	Rotterdam
United States	Lowcountry Lung and Critical Care	Charleston	South Carolina
United States	Critical Care, Pulmonary and Sleep Associates	Lakewood	Colorado
United States	Renown Regional Medical Center	Reno	Nevada
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4, Week 8, and Week 12.		up to 12 weeks
Secondary	Change from baseline in CC/hr at Week 4, Week 8, Week 12.		up to 12 weeks
Secondary	Forced Vital Capacity (FVC, mL) at baseline		at baseline
Secondary	FVC (mL) at Week 12		at Week 12
Secondary	Change from baseline in FVC (mL) at Week 12		up to 12 weeks
Secondary	Percentage (%) of analysable data per 24-hour recording (feasibility of remote cough data capture)		up to 12 weeks
Secondary	Number of successful completion of all elements of remote visit (feasibility of hybrid study design)		up to 12 weeks

External Links

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