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

Boehringer Ingelheim53 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pulmonary Fibrosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

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, United States

Lowcountry Lung and Critical Care

Charleston, South Carolina, United States

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, Belgium

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsklinikum Jena

Jena, Germany

...and 3 more locations

Outcomes

Primary Outcomes

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.

Time frame: At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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