Pulmonary FibrosisNCT05670587
A Study in People With Pulmonary Fibrosis to Monitor Cough With a Wearable Device
A study testing A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection in people with Pulmonary Fibrosis, run by Boehringer Ingelheim at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 16 Jan 2023to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States4 sites
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406
Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado, 80228
Renown Regional Medical Center
Reno, Nevada, 89502
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Belgium4 sites
Aalst - HOSP Onze-Lieve-Vrouw
Aalst, 9300
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
Kortrijk - HOSP AZ Groeninge Kennedylaan
Kortrijk, 8500
Roeselare - HOSP AZ Delta
Roeselare, 8800
Netherlands3 sites
Rijnstate Hospital
Arnhem, 6815 AD
Amphia Ziekenhuis
Breda, 4818 CK
Erasmus Medisch Centrum
Rotterdam, 3015 CP
Germany2 sites
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitätsklinikum Jena
Jena, 07747
About this study
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
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.
Read more
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.
- Conditions
- Pulmonary Fibrosis
- Being tested
- A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collectionDevice
A wearable cough monitoring device, the Strados Labs Remote Electronic Stethoscope Platform (RESP)ᵀᴹ sensor, with an accompanying mobile application (App) for data collection.
| Study group | Role | What they receive |
|---|---|---|
| Participants with IPF or non IPF pulmonary fibrosis | Experimental | Participants with IPF or non IPF pulmonary fibrosis. Receives: Device: A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (Visit 2), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).
Secondary outcomes (5)
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.
Measured: At baseline (Visit 2), Week 4, (Visit 4) Week 8 (Visit 5) and at Day 82 (Visit 6).
Forced Vital Capacity (FVC) at Baseline and at Week 12
Forced Vital Capacity (FVC) at baseline and at Week 12.
Measured: 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.
Measured: 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.
Measured: 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:
- 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.
Measured: At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start16 Jan 2023
- Primary completion22 Feb 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670587
- Sponsor's protocol ID
- 1490-0005
- Status last verified
- Feb 2025
- First submitted
- 15 Dec 2022
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05670587
- Acronym / sponsor ID
- 1490-0005
- Conditions
- Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Posted 11 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with IPF or non IPF pulmonary fibrosis | Experimental | Device: A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collectionParticipants with IPF or non IPF pulmonary fibrosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collectionA wearable cough monitoring device, the Strados Labs Remote Electronic Stethoscope Platform (RESP)ᵀᴹ sensor, with an accompanying mobile application (App) for data collection. | Device | Participants with IPF or non IPF pulmonary fibrosis |
Primary outcome
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).
Cough count per hour (CC/hr) measured over a 24-hour period at baseline visit, Week 4, Week 8, and at Day 82.
5 secondary outcomes
Change From Baseline (CfB) in Cough Count Per Hour (CC/h) at 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).
Forced Vital Capacity (FVC) at Baseline and at Week 12
Time frame: At baseline (Visit 2) and at Week 12 (Visit 7).
Change From Baseline in Forced Vital Capacity (FVC) at Week 12
Time frame: 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)
Time frame: 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)
Time frame: At Day 3 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and at Day 82 (Visit 6).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection in people with Pulmonary Fibrosis, run by Boehringer Ingelheim at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Belgium, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.