Digital Auscultation Test - IPF Data Collection

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Device: Littmann ®

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Coswig, Germany, 01640
    • Fachkrankenhaus Coswig GmbH
  • Donaustauf, Germany, 93093
    • Klinik Donaustauf
  • Essen, Germany, 45239
    • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Gießen, Germany, 35392
    • Universitatsklinikum Gießen und Marburg GmbH
  • Großhansdorf, Germany, 22927
    • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69126
    • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
  • Konstanz, Germany, 78464
    • Klinikum Konstanz
  • Solingen, Germany, 42699
    • Krankenhaus Bethanien gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: All participants	Device: Littmann ®; electronic stethoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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; = 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.	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)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2018
• Primary Completion (ACTUAL): January 3, 2019
• Study Completion (ACTUAL): January 3, 2019

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (ACTUAL): April 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 0352-2119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No