Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Littmann ® | Device | electronic stethoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Day 1 (Visit 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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;
|
Not provided
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,
Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the study
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany | |||
| Fachkrankenhaus Coswig GmbH |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Patients Entered Set (ENT): ENT included all participants (Main Study and Sub Study) for whom visit data were available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Non-IPF Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | 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. | Posted | Mean | Standard Deviation | PercentageOfAuscultationPointsCollected | Day 1 (Visit 1) |
|
Not provided
No adverse events were collected for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 17, 2018 | Dec 20, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2018 | Dec 20, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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). | 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). | 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". | Day 1 (Visit 1) |
| Coswig |
| 01640 |
| Germany |
| Klinik Donaustauf | Donaustauf | 93093 | Germany |
| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen | 45239 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH | Giessen | 35392 | Germany |
| Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH | Großhansdorf | 22927 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Klinikum Konstanz | Konstanz | 78464 | Germany |
| Krankenhaus Bethanien gGmbH | Solingen | 42699 | Germany |
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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and ethnicity data were not collected for this trial. | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | 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;
| All Patients Entered Set (ENT): ENT included all participants (Main Study and Sub Study) for whom visit data were available. | Posted | Number | Participants | Day 1 (Visit 1) |
|
|
|
| Secondary | 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. | ENT | Posted | Number | Participants | Day 1 (Visit 1) |
|
|
|
| Secondary | 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). | ENT | Posted | Count of Participants | Participants | Day 1 (Visit 1) |
|
|
|
| Secondary | 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). | ENT | Posted | Mean | Standard Deviation | Kilogram/ meter^2 (kg/ m^2) | Day 1 (Visit 1) |
|
|
|
| Secondary | 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". | Substudy- All participants entered substudy set (ENSST): This included all participants for whom visit data were available and who took part in the substudy. | Posted | Mean | Standard Deviation | PercentageOfAuscultationPointsCollected | Day 1 (Visit 1) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| 2 |
|
| 3 |
|
| 4 |
|
| ≥2 month short periods (DT) |
|
| FrequentCoughWithoutInterferingUsualActivities(DT) |
|
| FrequentCoughWithInterferingUsualActivities (DT) |
|
| Distressing cough most of the day (DT) |
|
| No cough (NT) |
|
| Cough on waking only/cough ongoing toSleepOnly(NT) |
|
| Awoken once or woken early due to coughing (NT) |
|
| Frequent waking due to cough (NT) |
|
| Frequent coughs, most of the night (NT) |
|
| Patients with sputum |
|
| Never smoked |
|