Back to resultsDigital Auscultation Test - IPF Data Collection
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Littmann ®
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis
Eligibility Criteria
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
Sites / Locations
- Klinikum Chemnitz gGmbH
- Fachkrankenhaus Coswig GmbH
- Klinik Donaustauf
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
- Universitätsklinikum Gießen und Marburg GmbH
- Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
- Medizinische Hochschule Hannover
- Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
- Klinikum Konstanz
- Krankenhaus Bethanien gGmbH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
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.
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.
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).
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).
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".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03503188
Brief Title
Digital Auscultation Test - IPF Data Collection
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
January 3, 2019 (Actual)
Study Completion Date
January 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Littmann ®
Intervention Description
electronic stethoscope
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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)
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)
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)
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)
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Fachkrankenhaus Coswig GmbH
City
Coswig
ZIP/Postal Code
01640
Country
Germany
Facility Name
Klinik Donaustauf
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Klinikum Konstanz
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
Krankenhaus Bethanien gGmbH
City
Solingen
ZIP/Postal Code
42699
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
Digital Auscultation Test - IPF Data Collection
We'll reach out to this number within 24 hrs