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Completed

NCT Number: NCT03503188

Digital Auscultation Test - IPF Data Collection

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinikum Chemnitz gGmbH, Chemnitz, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Littmann ®

Device

electronic stethoscope

Primary outcomes

  1. Main Study - The Percentage of Collected Auscultation Points

    Time frame: 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 outcomes

  1. Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale

    Time frame: 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;

    • = 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.

  2. Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum

    Time frame: 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.

  3. Entire Study - Smoking Status

    Time frame: 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).

  4. Entire Study - Body Mass Index (BMI)

    Time frame: 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).

  5. Sub Study - The Percentage of Collected Auscultation Points

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2018
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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