Pulmonary Fibrosis
Conditions
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.
Interventions
DEVICEA wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection
A wearable cough monitoring device, the Strados Labs Remote Electronic Stethoscope Platform (RESP)ᵀᴹ sensor, with an accompanying mobile application (App) for data collection.
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82 | 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. |
| Forced Vital Capacity (FVC) at Baseline and at Week 12 | At baseline (Visit 2) and at Week 12 (Visit 7). | Forced Vital Capacity (FVC) at baseline and at Week 12. |
| Change From Baseline in Forced Vital Capacity (FVC) at Week 12 | At baseline (Visit 2) and at Week 12 (Visit 7). | Change from baseline in Forced Vital Capacity (FVC) at Week 12. |
| Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture) | 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. |
| Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design) | 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. |
Countries
Belgium, Germany, Netherlands, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Participants With IPF or Non IPF Pulmonary Fibrosis |
|---|---|
| Age, Continuous | 70.4 Years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
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).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With IPF or Non IPF Pulmonary Fibrosis | Cough Count Per Hour (CC/hr) Measured Over a 24-hour Period at Baseline Visit, Week 4, Week 8, and at Day 82 | Baseline | 10.79 Cough count per hour | Standard Deviation 14.57 |
| Participants With IPF or Non IPF Pulmonary Fibrosis | 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 |
| Participants With IPF or Non IPF Pulmonary Fibrosis | 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 | 10.36 Cough count per hour | Standard Deviation 18.03 |
| Participants With IPF or Non IPF Pulmonary Fibrosis | 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 |
Secondary
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).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With IPF or Non IPF Pulmonary Fibrosis | Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82 | CfB at Week 4 | 1.42 Cough count per hour | Standard Deviation 9.67 |
| Participants With IPF or Non IPF Pulmonary Fibrosis | Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82 | CfB at Week 8 | 0.12 Cough count per hour | Standard Deviation 8.82 |
| Participants With IPF or Non IPF Pulmonary Fibrosis | Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at Week 4, Week 8 and at Day 82 | CfB at Day 82 | 1.03 Cough count per hour | Standard Deviation 9.01 |
Comparison: Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 4.95% CI: [0.76, 1.18]
Comparison: Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 8.95% CI: [0.64, 1.11]
Comparison: Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Day 82.95% CI: [0.75, 1.29]
Secondary
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).
Population: Entered Set (ES): All subjects entered into the study. Only participants with non-missing data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With IPF or Non IPF Pulmonary Fibrosis | Change From Baseline in Forced Vital Capacity (FVC) at Week 12 | -23.9 Milliliter (mL) | Standard Deviation 388.2 |
Secondary
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).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With IPF or Non IPF Pulmonary Fibrosis | Forced Vital Capacity (FVC) at Baseline and at Week 12 | Baseline | 3073.8 Milliliter (mL) | Standard Deviation 881.6 |
| Participants With IPF or Non IPF Pulmonary Fibrosis | Forced Vital Capacity (FVC) at Baseline and at Week 12 | Week 12 | 3021.1 Milliliter (mL) | Standard Deviation 869.3 |
Secondary
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).
Population: Entered Set: All subjects entered into the study. Only participants with non-missing data at the respective timepoint were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With IPF or Non IPF Pulmonary Fibrosis | Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design) | Successful completion on Day 3 | 34 Participants |
| Participants With IPF or Non IPF Pulmonary Fibrosis | Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design) | Successful completion on Week 4 | 36 Participants |
| Participants With IPF or Non IPF Pulmonary Fibrosis | Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design) | Successful completion on Week 8 | 33 Participants |
| Participants With IPF or Non IPF Pulmonary Fibrosis | Number of Successful Completion of All Elements of Remote Visit (Feasibility of Hybrid Study Design) | Successful completion on Day 82 | 31 Participants |
Secondary
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).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With IPF or Non IPF Pulmonary Fibrosis | Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture) | Baseline | 92.0 Percentage (%) | Standard Deviation 20.6 |
| Participants With IPF or Non IPF Pulmonary Fibrosis | Percentage (%) of Analysable Cough Device Data Per 24-hour Recording (Feasibility of Remote Cough Data Capture) | Week 4 | 93.6 Percentage (%) | Standard Deviation 19.9 |
| Participants With IPF or Non IPF Pulmonary Fibrosis | 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 |
| Participants With IPF or Non IPF Pulmonary Fibrosis | 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 |