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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with IPF or non IPF pulmonary fibrosis | Experimental | Participants with IPF or non IPF pulmonary fibrosis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection | Device | A wearable cough monitoring device, the Strados Labs Remote Electronic Stethoscope Platform (RESP)ᵀᴹ sensor, with an accompanying mobile application (App) for data collection. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (Visit 2), Week 4, (Visit 4) Week 8 (Visit 5) and at Day 82 (Visit 6). |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Critical Care, Pulmonary and Sleep Associates | Lakewood | Colorado | 80228 | United States | ||
| Renown Regional Medical Center |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 16, 2022 | Feb 10, 2025 |
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| Forced Vital Capacity (FVC) at Baseline and at Week 12 |
Forced Vital Capacity (FVC) at baseline and at Week 12. |
| 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. | 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. | 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:
| At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6). |
| Reno |
| Nevada |
| 89502 |
| United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | United States |
| Aalst - HOSP Onze-Lieve-Vrouw | Aalst | 9300 | Belgium |
| Jessa Ziekenhuis - Campus Virga Jesse | Hasselt | 3500 | Belgium |
| Kortrijk - HOSP AZ Groeninge Kennedylaan | Kortrijk | 8500 | Belgium |
| Roeselare - HOSP AZ Delta | Roeselare | 8800 | Belgium |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Jena | Jena | 07747 | Germany |
| Rijnstate Hospital | Arnhem | 6815 AD | Netherlands |
| Amphia Ziekenhuis | Breda | 4818 CK | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 CP | Netherlands |
| COMPLETED | Completed planned observation period |
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| NOT COMPLETED |
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Entered Set (ES): All subjects entered into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Entered Set (ES): All subjects entered into the study. Only participants with non-missing data at the respective timepoints were included in the analysis. | Posted | Mean | Standard Deviation | Cough count per hour | At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6). |
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| 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. | 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. | Posted | Mean | Standard Deviation | Cough count per hour | At baseline (Visit 2), Week 4, (Visit 4) Week 8 (Visit 5) and at Day 82 (Visit 6). |
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| Secondary | Forced Vital Capacity (FVC) at Baseline and at Week 12 | Forced Vital Capacity (FVC) at baseline and at Week 12. | Entered Set (ES): All subjects entered into the study. Only participants with non-missing data at the respective timepoint were included in the analysis. | Posted | Mean | Standard Deviation | Milliliter (mL) | At baseline (Visit 2) and at Week 12 (Visit 7). |
|
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| Secondary | Change From Baseline in Forced Vital Capacity (FVC) at Week 12 | Change from baseline in Forced Vital Capacity (FVC) at Week 12. | Entered Set (ES): All subjects entered into the study. Only participants with non-missing data were included in the analysis. | Posted | Mean | Standard Deviation | Milliliter (mL) | At baseline (Visit 2) and at Week 12 (Visit 7). |
|
| ||||||||||||||||||||||||||||
| 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. | Entered Set (ES): All subjects entered into the study. Only participants with non-missing data at the respective timepoint were included in the analysis. | Posted | Mean | Standard Deviation | Percentage (%) | At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6). |
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| 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:
| Entered Set: All subjects entered into the study. Only participants with non-missing data at the respective timepoint were included in the analysis. | Posted | Count of Participants | Participants | At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6). |
|
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All-cause mortality, serious and other adverse events: From study start until the individual subject's end of trial visit (V7), up to 12 weeks and 5 days.
Entered Set (ES): All subjects entered into the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 53 | 0 | 53 | 0 | 53 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 9, 2024 | Feb 10, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Week 8 |
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| Day 82 |
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