Digital Auscultation Test - IPF Data Collection

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03503188
• Collaborator: (none)
• Enrollment: 274
• Locations: 10
• Arm: 1
• Actual Duration (Months): 9.2
• Patients Per Site: 27.4
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Device: Littmann ®	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 274 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 28, 2018
• Actual Primary Completion Date: Jan 3, 2019
• Actual Study Completion Date: Jan 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All participants	Device: Littmann ®; electronic stethoscope

Outcome Measures

Primary Outcome Measures

1. Main Study - The Percentage of Collected Auscultation Points [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".

Secondary Outcome Measures

1. Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale [Day 1 (Visit 1)]

   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.

2. Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum [Day 1 (Visit 1)]

   Number of participants that reported symptoms of respiratory disease (Cough and Sputum) for day time (DT) and night time (NT) is presented.

3. Entire Study - Smoking Status [Day 1 (Visit 1)]

   Smoking status is presented as ex-smokers, currently smokers and never smoked participants for main and sub-study combined (entire study).

4. Entire Study - Body Mass Index (BMI) [Day 1 (Visit 1)]

   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).

5. Sub Study - The Percentage of Collected Auscultation Points [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 3200 and the Ekuore One stethoscope. The unit of the measure is "Percentage of auscultation points collected per participants".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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,

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Chemnitz gGmbH	Chemnitz		Germany	09116
2	Fachkrankenhaus Coswig GmbH	Coswig		Germany	01640
3	Klinik Donaustauf	Donaustauf		Germany	93093
4	Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH	Essen		Germany	45239
5	Universitätsklinikum Gießen und Marburg GmbH	Gießen		Germany	35392
6	Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH	Großhansdorf		Germany	22927
7	Medizinische Hochschule Hannover	Hannover		Germany	30625
8	Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg	Heidelberg		Germany	69126
9	Klinikum Konstanz	Konstanz		Germany	78464
10	Krankenhaus Bethanien gGmbH	Solingen		Germany	42699

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 17, 2018
• Statistical Analysis Plan - Jul 26, 2018

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03503188
• Other Study ID Numbers: 0352-2119
• First Posted: Apr 19, 2018
• Last Update Posted: Jan 27, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	IPF Group	Non-IPF Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	128	146
Entered in the Entire Study	128	145
Main Study	99	101
Sub-study	29	44
COMPLETED	128	145
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	IPF Group	Non-IPF Group	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	128	145	273
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	72.1 (7.9)	64.1 (9.9)	67.8 (9.8)
Sex: Female, Male (Count of Participants)
Female	26 20.3%	76 52.4%	102 37.4%
Male	102 79.7%	69 47.6%	171 62.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Main Study - The Percentage of Collected Auscultation Points
Description	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".
Time Frame	Day 1 (Visit 1)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	IPF Group	Non-IPF Group
Arm/Group Description	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.	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.
Measure Participants	99	101
Mean (Standard Deviation) [PercentageOfAuscultationPointsCollected]	100 (0.0)	100 (0.0)

2. Secondary Outcome

Title	Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale
Description	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.
Time Frame	Day 1 (Visit 1)

Outcome Measure Data

Analysis Population Description

All Patients Entered Set (ENT): ENT included all participants (Main Study and Sub Study) for whom visit data were available.

Arm/Group Title	IPF Group	Non-IPF Group
Arm/Group Description	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.	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.
Measure Participants	128	145
0	29 22.7%	40 27.6%
1	41 32%	28 19.3%
2	31 24.2%	44 30.3%
3	23 18%	28 19.3%
4	4 3.1%	5 3.4%

3. Secondary Outcome

Title	Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
Description	Number of participants that reported symptoms of respiratory disease (Cough and Sputum) for day time (DT) and night time (NT) is presented.
Time Frame	Day 1 (Visit 1)

Outcome Measure Data

Analysis Population Description

ENT

Arm/Group Title	IPF Group	Non-IPF Group
Arm/Group Description	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.	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.
Measure Participants	128	145
No cough (DT)	41 32%	64 44.1%
1 month short period (DT)	27 21.1%	16 11%
≥2 month short periods (DT)	13 10.2%	27 18.6%
FrequentCoughWithoutInterferingUsualActivities(DT)	27 21.1%	17 11.7%
FrequentCoughWithInterferingUsualActivities (DT)	14 10.9%	18 12.4%
Distressing cough most of the day (DT)	6 4.7%	3 2.1%
No cough (NT)	97 75.8%	99 68.3%
Cough on waking only/cough ongoing toSleepOnly(NT)	23 18%	19 13.1%
Awoken once or woken early due to coughing (NT)	3 2.3%	14 9.7%
Frequent waking due to cough (NT)	5 3.9%	9 6.2%
Frequent coughs, most of the night (NT)	0 0%	4 2.8%
Patients with sputum	25 19.5%	30 20.7%

4. Secondary Outcome

Title	Entire Study - Smoking Status
Description	Smoking status is presented as ex-smokers, currently smokers and never smoked participants for main and sub-study combined (entire study).
Time Frame	Day 1 (Visit 1)

Outcome Measure Data

Analysis Population Description

ENT

Arm/Group Title	IPF Group	Non-IPF Group
Arm/Group Description	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.	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.
Measure Participants	128	145
Ex-smoker	85 66.4%	78 53.8%
Currently smokes	1 0.8%	26 17.9%
Never smoked	42 32.8%	41 28.3%

5. Secondary Outcome

Title	Entire Study - Body Mass Index (BMI)
Description	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).
Time Frame	Day 1 (Visit 1)

Outcome Measure Data

Analysis Population Description

ENT

Arm/Group Title	IPF Group	Non-IPF Group
Arm/Group Description	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.	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.
Measure Participants	128	145
Mean (Standard Deviation) [Kilogram/ meter^2 (kg/ m^2)]	25.31 (2.46)	23.99 (3.30)

6. Secondary Outcome

Title	Sub Study - The Percentage of Collected Auscultation Points
Description	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".
Time Frame	Day 1 (Visit 1)

Outcome Measure Data

Analysis Population Description

Substudy- All participants entered substudy set (ENSST): This included all participants for whom visit data were available and who took part in the substudy.

Arm/Group Title	IPF Group	Non-IPF Group
Arm/Group Description	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.	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.
Measure Participants	29	44
Littmann 3200	100 (0.0)	100 (0.0)
Ekuore One stethoscope	100 (0.0)	100 (0.0)

Adverse Events

Adverse Event Reporting Description	No adverse events were collected for this study.
Arm/Group Title	IPF Group		Non-IPF Group
Arm/Group Description	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.		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.
All Cause Mortality
	IPF Group		Non-IPF Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	IPF Group		Non-IPF Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	IPF Group		Non-IPF Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.