NCT05670587

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

Completed NA Results posted Last updated 11 March 2025

What this trial tests

NA trial testing A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection in Pulmonary Fibrosis in 53 participants. Completed in 7 March 2024.

Timeline

16 January 2023

Primary endpoint
22 February 2024

7 March 2024

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	53
Start date	16 January 2023
Primary completion	22 February 2024
Estimated completion	7 March 2024
Sites	13 locations across Belgium, Netherlands, United States, Germany

Drugs / interventions tested

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

Conditions studied

• Pulmonary Fibrosis — all drugs for Pulmonary Fibrosis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82 Primary · At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).

Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4, Week 8, and at Day 82.

Baseline

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	10.79	± 14.57

Week 4

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	12.63	± 19.02

Week 8

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	10.36	± 18.03

Day 82

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	12.45	± 17.15

Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82 Secondary · At baseline (Visit 2), Week 4, (Visit 4) Week 8 (Visit 5) and at Day 82 (Visit 6).

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.

CfB at Week 4

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	1.42	± 9.67

CfB at Week 8

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	0.12	± 8.82

CfB at Day 82

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	1.03	± 9.01

Forced Vital Capacity (FVC) at Baseline and at Week 12 Secondary · At baseline (Visit 2) and at Week 12 (Visit 7).

Forced Vital Capacity (FVC) at baseline and at Week 12.

Baseline

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	3073.8	± 881.6

Week 12

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	3021.1	± 869.3

Change From Baseline in Forced Vital Capacity (FVC) at Week 12 Secondary · At baseline (Visit 2) and at Week 12 (Visit 7).

Change from baseline in Forced Vital Capacity (FVC) at Week 12.

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	-23.9	± 388.2

Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture) Secondary · At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).

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.

Baseline

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	92.0	± 20.6

Week 4

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	93.6	± 19.9

Week 8

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	82.2	± 32.2

Day 82

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	93.1	± 18.1

Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design) Secondary · At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).

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.

Successful completion on Day 3

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	34

Successful completion on Week 4

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	36

Successful completion on Week 8

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	33

Successful completion on Day 82

Group	Value	95% CI
Participants With IPF or Non IPF Pulmonary Fibrosis	31

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.