Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
DEVICELittmann ®
electronic stethoscope
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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; 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. |
| 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. |
| 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). |
| 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). |
| 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. |
Countries
Germany
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 128 |
| 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. | 145 |
| Total | 273 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Non eligible in the sub study | 0 | 1 |
Baseline characteristics
| Characteristic | IPF Group | Non-IPF Group | Total |
|---|---|---|---|
| Age, Continuous | 72.1 Years STANDARD_DEVIATION 7.9 | 64.1 Years STANDARD_DEVIATION 9.9 | 67.8 Years STANDARD_DEVIATION 9.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 26 Participants | 76 Participants | 102 Participants |
| Sex: Female, Male Male | 102 Participants | 69 Participants | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPF Group | Main Study - The Percentage of Collected Auscultation Points | 100 PercentageOfAuscultationPointsCollected | Standard Deviation 0 |
| Non-IPF Group | Main Study - The Percentage of Collected Auscultation Points | 100 PercentageOfAuscultationPointsCollected | Standard Deviation 0 |
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).
Time frame: Day 1 (Visit 1)
Population: ENT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPF Group | Entire Study - Body Mass Index (BMI) | 25.31 Kilogram/ meter^2 (kg/ m^2) | Standard Deviation 2.46 |
| Non-IPF Group | Entire Study - Body Mass Index (BMI) | 23.99 Kilogram/ meter^2 (kg/ m^2) | Standard Deviation 3.3 |
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.
Time frame: Day 1 (Visit 1)
Population: ENT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | No cough (DT) | 41 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | 1 month short period (DT) | 27 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | ≥2 month short periods (DT) | 13 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | FrequentCoughWithoutInterferingUsualActivities(DT) | 27 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | FrequentCoughWithInterferingUsualActivities (DT) | 14 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Distressing cough most of the day (DT) | 6 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | No cough (NT) | 97 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Cough on waking only/cough ongoing toSleepOnly(NT) | 23 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Awoken once or woken early due to coughing (NT) | 3 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Frequent waking due to cough (NT) | 5 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Frequent coughs, most of the night (NT) | 0 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Patients with sputum | 25 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Frequent coughs, most of the night (NT) | 4 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | No cough (DT) | 64 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | No cough (NT) | 99 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | 1 month short period (DT) | 16 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Frequent waking due to cough (NT) | 9 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | ≥2 month short periods (DT) | 27 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Cough on waking only/cough ongoing toSleepOnly(NT) | 19 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | FrequentCoughWithoutInterferingUsualActivities(DT) | 17 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Patients with sputum | 30 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | FrequentCoughWithInterferingUsualActivities (DT) | 18 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Awoken once or woken early due to coughing (NT) | 14 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum | Distressing cough most of the day (DT) | 3 Participants |
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; 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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 1 | 41 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 3 | 23 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 2 | 31 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 4 | 4 Participants |
| IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 0 | 29 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 4 | 5 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 0 | 40 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 1 | 28 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 2 | 44 Participants |
| Non-IPF Group | Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale | 3 | 28 Participants |
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).
Time frame: Day 1 (Visit 1)
Population: ENT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IPF Group | Entire Study - Smoking Status | Ex-smoker | 85 Participants |
| IPF Group | Entire Study - Smoking Status | Currently smokes | 1 Participants |
| IPF Group | Entire Study - Smoking Status | Never smoked | 42 Participants |
| Non-IPF Group | Entire Study - Smoking Status | Ex-smoker | 78 Participants |
| Non-IPF Group | Entire Study - Smoking Status | Currently smokes | 26 Participants |
| Non-IPF Group | Entire Study - Smoking Status | Never smoked | 41 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IPF Group | Sub Study - The Percentage of Collected Auscultation Points | Littmann 3200 | 100 PercentageOfAuscultationPointsCollected | Standard Deviation 0 |
| IPF Group | Sub Study - The Percentage of Collected Auscultation Points | Ekuore One stethoscope | 100 PercentageOfAuscultationPointsCollected | Standard Deviation 0 |
| Non-IPF Group | Sub Study - The Percentage of Collected Auscultation Points | Littmann 3200 | 100 PercentageOfAuscultationPointsCollected | Standard Deviation 0 |
| Non-IPF Group | Sub Study - The Percentage of Collected Auscultation Points | Ekuore One stethoscope | 100 PercentageOfAuscultationPointsCollected | Standard Deviation 0 |