Clinical trial NCT05670587: A Study in People With Pulmonary Fibrosis to Monitor Cough With a Wearable Device
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-01-04
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82
timeFrame: At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).
Secondary outcomes:
measure: Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82
timeFrame: At baseline (Visit 2), Week 4, (Visit 4) Week 8 (Visit 5) and at Day 82 (Visit 6).
measure: Forced Vital Capacity (FVC) at Baseline and at Week 12
timeFrame: At baseline (Visit 2) and at Week 12 (Visit 7).
measure: Change From Baseline in Forced Vital Capacity (FVC) at Week 12
timeFrame: At baseline (Visit 2) and at Week 12 (Visit 7).
measure: Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture)
timeFrame: At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).
measure: Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design)
timeFrame: At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Critical Care, Pulmonary and Sleep Associates
state: Colorado
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Aalst
country: Belgium
facility: Aalst - HOSP Onze-Lieve-Vrouw
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: Kortrijk
country: Belgium
facility: Kortrijk - HOSP AZ Groeninge Kennedylaan
city: Roeselare
country: Belgium
facility: Roeselare - HOSP AZ Delta
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
Study officials:
References: