Trial Outcomes & Findings for Digital Auscultation Test - IPF Data Collection (NCT NCT03503188)
NCT ID: NCT03503188
Last Updated: 2020-01-27
Results Overview
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".
COMPLETED
PHASE4
274 participants
Day 1 (Visit 1)
2020-01-27
Participant Flow
Multicenter, single-visit study to collect new data of participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) and symptomatic controls (non-IPF). Participants were grouped based on their diagnosis at screening. Data for main study was collected from April2018 to July2018 and for substudy from September2018 to January2019.
All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered in the trial if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
IPF Group
All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
|
Non-IPF Group
All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
146
|
|
Overall Study
Entered in the Entire Study
|
128
|
145
|
|
Overall Study
Main Study
|
99
|
101
|
|
Overall Study
Sub-study
|
29
|
44
|
|
Overall Study
COMPLETED
|
128
|
145
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
IPF Group
All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
|
Non-IPF Group
All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
|
|---|---|---|
|
Overall Study
Non eligible in the sub study
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
IPF Group
n=128 Participants
All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
|
Non-IPF Group
n=145 Participants
All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.1 Years
STANDARD_DEVIATION 7.9 • n=128 Participants
|
64.1 Years
STANDARD_DEVIATION 9.9 • n=145 Participants
|
67.8 Years
STANDARD_DEVIATION 9.8 • n=273 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=128 Participants
|
76 Participants
n=145 Participants
|
102 Participants
n=273 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=128 Participants
|
69 Participants
n=145 Participants
|
171 Participants
n=273 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 1 (Visit 1)Population: Main study- All participants entered main study set (ENMST): This included all participants for whom visit data were available and who did not take part in the substudy.
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".
Outcome measures
| Measure |
IPF Group
n=99 Participants
All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
|
Non-IPF Group
n=101 Participants
All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
|
|---|---|---|
|
Main Study - The Percentage of Collected Auscultation Points
|
100 PercentageOfAuscultationPointsCollected
Standard Deviation 0.0
|
100 PercentageOfAuscultationPointsCollected
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Day 1 (Visit 1)Population: All Patients Entered Set (ENT): ENT included all participants (Main Study and Sub Study) for whom visit data were available.
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; 1. = I get short of breath when hurrying on level ground or walking up a slight hill; 2. = 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; 3. = I stop for breath after walking about 100 meters or after a few minutes on level ground; 4. = I am too breathless to leave the house or I am breathless when dressing.
Outcome measures
| Measure |
IPF Group
n=128 Participants
All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
|
Non-IPF Group
n=145 Participants
All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
|
|---|---|---|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale
3
|
23 Participants
|
28 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale
0
|
29 Participants
|
40 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale
1
|
41 Participants
|
28 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale
2
|
31 Participants
|
44 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale
4
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Visit 1)Population: ENT
Number of participants that reported symptoms of respiratory disease (Cough and Sputum) for day time (DT) and night time (NT) is presented.
Outcome measures
| Measure |
IPF Group
n=128 Participants
All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
|
Non-IPF Group
n=145 Participants
All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
|
|---|---|---|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
Distressing cough most of the day (DT)
|
6 Participants
|
3 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
No cough (NT)
|
97 Participants
|
99 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
No cough (DT)
|
41 Participants
|
64 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
1 month short period (DT)
|
27 Participants
|
16 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
≥2 month short periods (DT)
|
13 Participants
|
27 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
FrequentCoughWithoutInterferingUsualActivities(DT)
|
27 Participants
|
17 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
FrequentCoughWithInterferingUsualActivities (DT)
|
14 Participants
|
18 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
Cough on waking only/cough ongoing toSleepOnly(NT)
|
23 Participants
|
19 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
Awoken once or woken early due to coughing (NT)
|
3 Participants
|
14 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
Frequent waking due to cough (NT)
|
5 Participants
|
9 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
Frequent coughs, most of the night (NT)
|
0 Participants
|
4 Participants
|
|
Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
Patients with sputum
|
25 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Visit 1)Population: ENT
Smoking status is presented as ex-smokers, currently smokers and never smoked participants for main and sub-study combined (entire study).
Outcome measures
| Measure |
IPF Group
n=128 Participants
All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
|
Non-IPF Group
n=145 Participants
All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
|
|---|---|---|
|
Entire Study - Smoking Status
Ex-smoker
|
85 Participants
|
78 Participants
|
|
Entire Study - Smoking Status
Currently smokes
|
1 Participants
|
26 Participants
|
|
Entire Study - Smoking Status
Never smoked
|
42 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Visit 1)Population: ENT
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).
Outcome measures
| Measure |
IPF Group
n=128 Participants
All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
|
Non-IPF Group
n=145 Participants
All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
|
|---|---|---|
|
Entire Study - Body Mass Index (BMI)
|
25.31 Kilogram/ meter^2 (kg/ m^2)
Standard Deviation 2.46
|
23.99 Kilogram/ meter^2 (kg/ m^2)
Standard Deviation 3.30
|
SECONDARY outcome
Timeframe: Day 1 (Visit 1)Population: Substudy- All participants entered substudy set (ENSST): This included all participants for whom visit data were available and who took part in the substudy.
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".
Outcome measures
| Measure |
IPF Group
n=29 Participants
All the participants with confirmed diagnosis of idiopathic pulmonary disease (IPF) according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2011 guideline, based on their diagnosis at screening were included in this group.
|
Non-IPF Group
n=44 Participants
All the participants with the symptomatic control group (non-IPF group). Patients of this control group had to be diagnosed with a confirmed current condition of asthma, Chronic Obstructive Pulmonary Disease (COPD), upper respiratory tract infection, acute bronchitis or pneumonia as the symptoms of these diseases are similar to the symptoms of IPF, based on their diagnosis at screening were included in this group.
|
|---|---|---|
|
Sub Study - The Percentage of Collected Auscultation Points
Littmann 3200
|
100 PercentageOfAuscultationPointsCollected
Standard Deviation 0.0
|
100 PercentageOfAuscultationPointsCollected
Standard Deviation 0.0
|
|
Sub Study - The Percentage of Collected Auscultation Points
Ekuore One stethoscope
|
100 PercentageOfAuscultationPointsCollected
Standard Deviation 0.0
|
100 PercentageOfAuscultationPointsCollected
Standard Deviation 0.0
|
Adverse Events
IPF Group
Non-IPF Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
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