Trial Outcomes & Findings for A Study in People With Pulmonary Fibrosis to Monitor Cough With a Wearable Device (NCT NCT05670587)
NCT ID: NCT05670587
Last Updated: 2025-03-11
Results Overview
Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4, Week 8, and at Day 82.
COMPLETED
NA
53 participants
At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).
2025-03-11
Participant Flow
A multi-centre, non-randomised, low intervention, 12-week longitudinal pilot trial in patients with idiopathic pulmonary fibrosis (IPF) or non-IPF pulmonary fibrosis to monitor cough with a wearable device.
Each subject signed and dated an informed consent form (ICF) according to the local regulatory and legal requirements. All subjects were informed that they were free to withdraw their consent at any time during the trial without penalty or prejudice. The subjects were informed that their personal trial related data would be considered confidential and used by Boehringer Ingelheim in accordance with the local data protection laws.
Participant milestones
| Measure |
Participants With IPF or Non IPF Pulmonary Fibrosis
Participants with idiopathic pulmonary fibrosis (IPF) or non IPF pulmonary fibrosis. The Strados Remote Electronic Stethoscope Platform (RESP™) Wearable Cough Monitor, adhered to chest wall, was worn for 24 hours.
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|---|---|
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Overall Study
STARTED
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53
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Overall Study
COMPLETED
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50
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Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Participants With IPF or Non IPF Pulmonary Fibrosis
Participants with idiopathic pulmonary fibrosis (IPF) or non IPF pulmonary fibrosis. The Strados Remote Electronic Stethoscope Platform (RESP™) Wearable Cough Monitor, adhered to chest wall, was worn for 24 hours.
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|---|---|
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Overall Study
Withdrawal by Subject
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3
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Baseline Characteristics
A Study in People With Pulmonary Fibrosis to Monitor Cough With a Wearable Device
Baseline characteristics by cohort
| Measure |
Participants With IPF or Non IPF Pulmonary Fibrosis
n=53 Participants
Participants with idiopathic pulmonary fibrosis (IPF) or non IPF pulmonary fibrosis. The Strados Remote Electronic Stethoscope Platform (RESP™) Wearable Cough Monitor, adhered to chest wall, was worn for 24 hours.
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|---|---|
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Age, Continuous
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70.4 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
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Sex: Female, Male
Female
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15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).Population: Entered Set (ES): All subjects entered into the study. Only participants with non-missing data at the respective timepoints were included in the analysis.
Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4, Week 8, and at Day 82.
Outcome measures
| Measure |
Participants With IPF or Non IPF Pulmonary Fibrosis
n=53 Participants
Participants with idiopathic pulmonary fibrosis (IPF) or non IPF pulmonary fibrosis. The Strados Remote Electronic Stethoscope Platform (RESP™) Wearable Cough Monitor, adhered to chest wall, was worn for 24 hours.
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|---|---|
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Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82
Baseline
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10.79 Cough count per hour
Standard Deviation 14.57
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|
Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82
Week 4
|
12.63 Cough count per hour
Standard Deviation 19.02
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|
Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82
Week 8
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10.36 Cough count per hour
Standard Deviation 18.03
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|
Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82
Day 82
|
12.45 Cough count per hour
Standard Deviation 17.15
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SECONDARY outcome
Timeframe: At baseline (Visit 2), Week 4, (Visit 4) Week 8 (Visit 5) and at Day 82 (Visit 6).Population: Entered Set (ES): All subjects who entered into the study. Only participants with non-missing values at the respective timepoint were included in the analysis.
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.
Outcome measures
| Measure |
Participants With IPF or Non IPF Pulmonary Fibrosis
n=53 Participants
Participants with idiopathic pulmonary fibrosis (IPF) or non IPF pulmonary fibrosis. The Strados Remote Electronic Stethoscope Platform (RESP™) Wearable Cough Monitor, adhered to chest wall, was worn for 24 hours.
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|---|---|
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Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82
CfB at Week 8
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0.12 Cough count per hour
Standard Deviation 8.82
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|
Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82
CfB at Day 82
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1.03 Cough count per hour
Standard Deviation 9.01
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|
Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82
CfB at Week 4
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1.42 Cough count per hour
Standard Deviation 9.67
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SECONDARY outcome
Timeframe: At baseline (Visit 2) and at Week 12 (Visit 7).Population: Entered Set (ES): All subjects entered into the study. Only participants with non-missing data at the respective timepoint were included in the analysis.
Forced Vital Capacity (FVC) at baseline and at Week 12.
Outcome measures
| Measure |
Participants With IPF or Non IPF Pulmonary Fibrosis
n=53 Participants
Participants with idiopathic pulmonary fibrosis (IPF) or non IPF pulmonary fibrosis. The Strados Remote Electronic Stethoscope Platform (RESP™) Wearable Cough Monitor, adhered to chest wall, was worn for 24 hours.
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|---|---|
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Forced Vital Capacity (FVC) at Baseline and at Week 12
Baseline
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3073.8 Milliliter (mL)
Standard Deviation 881.6
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|
Forced Vital Capacity (FVC) at Baseline and at Week 12
Week 12
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3021.1 Milliliter (mL)
Standard Deviation 869.3
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SECONDARY outcome
Timeframe: At baseline (Visit 2) and at Week 12 (Visit 7).Population: Entered Set (ES): All subjects entered into the study. Only participants with non-missing data were included in the analysis.
Change from baseline in Forced Vital Capacity (FVC) at Week 12.
Outcome measures
| Measure |
Participants With IPF or Non IPF Pulmonary Fibrosis
n=49 Participants
Participants with idiopathic pulmonary fibrosis (IPF) or non IPF pulmonary fibrosis. The Strados Remote Electronic Stethoscope Platform (RESP™) Wearable Cough Monitor, adhered to chest wall, was worn for 24 hours.
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|---|---|
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Change From Baseline in Forced Vital Capacity (FVC) at Week 12
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-23.9 Milliliter (mL)
Standard Deviation 388.2
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SECONDARY outcome
Timeframe: At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).Population: Entered Set (ES): All subjects entered into the study. Only participants with non-missing data at the respective timepoint were included in the analysis.
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.
Outcome measures
| Measure |
Participants With IPF or Non IPF Pulmonary Fibrosis
n=53 Participants
Participants with idiopathic pulmonary fibrosis (IPF) or non IPF pulmonary fibrosis. The Strados Remote Electronic Stethoscope Platform (RESP™) Wearable Cough Monitor, adhered to chest wall, was worn for 24 hours.
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|---|---|
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Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture)
Baseline
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92.0 Percentage (%)
Standard Deviation 20.6
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Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture)
Week 4
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93.6 Percentage (%)
Standard Deviation 19.9
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|
Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture)
Week 8
|
82.2 Percentage (%)
Standard Deviation 32.2
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|
Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture)
Day 82
|
93.1 Percentage (%)
Standard Deviation 18.1
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SECONDARY outcome
Timeframe: At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).Population: Entered Set: All subjects entered into the study. Only participants with non-missing data at the respective timepoint were included in the analysis.
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.
Outcome measures
| Measure |
Participants With IPF or Non IPF Pulmonary Fibrosis
n=51 Participants
Participants with idiopathic pulmonary fibrosis (IPF) or non IPF pulmonary fibrosis. The Strados Remote Electronic Stethoscope Platform (RESP™) Wearable Cough Monitor, adhered to chest wall, was worn for 24 hours.
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|---|---|
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Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design)
Successful completion on Day 3
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34 Participants
|
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Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design)
Successful completion on Week 4
|
36 Participants
|
|
Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design)
Successful completion on Week 8
|
33 Participants
|
|
Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design)
Successful completion on Day 82
|
31 Participants
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Adverse Events
Participants With IPF or Non IPF Pulmonary Fibrosis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER