Digital Auscultation Test - IPF Data Collection

Phase 4

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Device: Littmann ®

• Registration Number: NCT03503188
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-27
• Study Start: 2018-03-28
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-19
• Primary Completion: 2019-01-03
• Study Completion: 2019-01-03
• Results First Submitted: 2019-12-20
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-14
• Results First Posted: 2020-01-27
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Littmann ®	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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 - 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.
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".

Trial Locations

Locations (10)

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH; 🇩🇪 Essen, Germany

Fachkrankenhaus Coswig GmbH; 🇩🇪 Coswig, Germany

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH; 🇩🇪 Großhansdorf, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Krankenhaus Bethanien gGmbH; 🇩🇪 Solingen, Germany

Klinikum Konstanz; 🇩🇪 Konstanz, Germany

Klinik Donaustauf; 🇩🇪 Donaustauf, Germany

Universitätsklinikum Gießen und Marburg GmbH; 🇩🇪 Gießen, Germany