Idiopathic Pulmonary FibrosisPhase 4NCT03503188
Digital Auscultation Test - IPF Data Collection
A Phase 4 study testing Littmann ® in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 10 sites in Germany.
Trial summary
The aim of this study is the data collection for patients with IPF and symptom matched controls to create a database of lung auscultation sounds and basic patient characteristics. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Littmann ®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 10 sitesGermany
- Study dates
- 28 Mar 2018to 3 Jan 2019
- Phase
- Phase 4
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients
- Age ≥ 45 years at the day of the study visit
- Diagnosis:
- For patients with confirmed Idiopathic Pulmonary Fibrosis (IPF) diagnosis - a clinical diagnosis of IPF within the last 24 months from the day of the study visit, according to the American Thoracic Society (ATS)/ European Respiratory Society (ERS) 2011 guideline [P11-07084] or
- For the symptom matched control - patients without a IPF diagnosis but with one of the confirmed current conditions as:
- asthma diagnosed according to GINA guidelines,
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- COPD diagnosed according to GOLD guidelines,
- pneumonia,
- upper respiratory tract infection, or
- acute bronchitis.
- Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the study
Who cannot join
- Any other current respiratory condition other than the pulmonary disease which qualified the patient eligibility based on inclusion criterion 3
- Any condition, according to investigator's assessment, which will not allow the patient to comply with protocol assessments or need a legal representative
- Patients with a history of lobectomy, pneumonectomy or lung transplant
- Patients with a Body Mass Index (BMI) >30,0 kg/m²
- Previous enrolment in this study
- Women who are pregnant
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Fachkrankenhaus Coswig GmbH
Coswig, 01640
Klinik Donaustauf
Donaustauf, 93093
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Universitätsklinikum Gießen und Marburg GmbH
Giessen, 35392
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Medizinische Hochschule Hannover
Hanover, 30625
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
Klinikum Konstanz
Konstanz, 78464
Krankenhaus Bethanien gGmbH
Solingen, 42699
About this study
Official title: Digital Auscultation Tool - Development of an Innovative Approach - Using Modern Technologies - to Improve the Diagnosis of Rare Lung Diseases - Expanded Data Collection Idiopathic Pulmonary Fibrosis
The aim of this study is the data collection for patients with IPF and symptom matched controls to create a database of lung auscultation sounds and basic patient characteristics.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Littmann ®
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Littmann ®Device
electronic stethoscope
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Not described Receives: Device: Littmann ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Study - The Percentage of Collected Auscultation Points
For each participants the auscultation sound files were collected at 12 points of the body. In each defined region of the participant's body, auscultation was to be performed to maximize the sound quality according to the investigator's experience. Auscultations were recorded using a Littmann Digital Stethoscope (Model 3200) and the 3M Littmann StethAssist software on a computer provided for the study. The unit of the measure is "Percentage of auscultation points collected per participants".
Measured: Day 1 (Visit 1)
Secondary outcomes (5)
Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale
Dyspnoea was assessed for participants as grade 0 and 1 of the modified MRC scale, ranging from 0 to 4 with '0´ being minor and '4´ being severe.
Where, 0 = I only get breathless with strenuous exercise;
- = I get short of breath when hurrying on level ground or walking up a slight hill;
- = On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace;
- = I stop for breath after walking about 100 meters or after a few minutes on level ground;
- = I am too breathless to leave the house or I am breathless when dressing.
Measured: Day 1 (Visit 1)
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
Number of participants that reported symptoms of respiratory disease (Cough and Sputum) for day time (DT) and night time (NT) is presented.
Measured: Day 1 (Visit 1)
Entire Study - Smoking Status
Smoking status is presented as ex-smokers, currently smokers and never smoked participants for main and sub-study combined (entire study).
Measured: Day 1 (Visit 1)
Entire Study - Body Mass Index (BMI)
BMI is defined as the body weight divided by the square of the body height is presented for main and sub-study combined (entire study).
Measured: Day 1 (Visit 1)
Sub Study - The Percentage of Collected Auscultation Points
For each participants the auscultation sound files were collected at 12 points of the body. In each defined region of the participant's body, auscultation was to be performed to maximize the sound quality according to the investigator's experience. Auscultations were recorded using a Littmann 3200 and the Ekuore One stethoscope. The unit of the measure is "Percentage of auscultation points collected per participants".
Measured: Day 1 (Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start28 Mar 2018
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
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 Idiopathic 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 274 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
- NCT03503188
- Sponsor's protocol ID
- 0352-2119
- Status last verified
- Jan 2020
- First submitted
- 27 Mar 2018
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Auscultation Tool - Development of an Innovative Approach - Using Modern Technologies - to Improve the Diagnosis of Rare Lung Diseases - Expanded Data Collection Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03503188
- Acronym / sponsor ID
- 0352-2119
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is the data collection for patients with IPF and symptom matched controls to create a database of lung auscultation sounds and basic patient characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Littmann ® |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients
- Age ≥ 45 years at the day of the study visit
- Diagnosis:
- Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the study
Key exclusion criteria (6 listed)
- Any other current respiratory condition other than the pulmonary disease which qualified the patient eligibility based on inclusion criterion 3
- Any condition, according to investigator's assessment, which will not allow the patient to comply with protocol assessments or need a legal representative
- Patients with a history of lobectomy, pneumonectomy or lung transplant
- Patients with a Body Mass Index (BMI) >30,0 kg/m²
- Previous enrolment in this study
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 |
|---|---|---|
| Littmann ®electronic stethoscope | Device | All participants |
Primary outcome
Main Study - The Percentage of Collected Auscultation Points
Time frame: Day 1 (Visit 1)
For each participants the auscultation sound files were collected at 12 points of the body. In each defined region of the participant's body, auscultation was to be performed to maximize the sound quality according to the investigator's experience. Auscultations were recorded using a Littmann Digital Stethoscope (Model 3200) and the 3M Littmann StethAssist software on a computer provided for the study. The unit of the measure is "Percentage of auscultation points collected per participants".
5 secondary outcomes
Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale
Time frame: Day 1 (Visit 1)
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
Time frame: Day 1 (Visit 1)
Entire Study - Smoking Status
Time frame: Day 1 (Visit 1)
Entire Study - Body Mass Index (BMI)
Time frame: Day 1 (Visit 1)
Sub Study - The Percentage of Collected Auscultation Points
Time frame: Day 1 (Visit 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Littmann ® in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 10 sites in Germany.
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 11 inclusion and 6 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2020). 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?
Main Study - The Percentage of Collected Auscultation Points (time frame: Day 1 (Visit 1)). 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 27 Jan 2020.