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Digital Auscultation Test - IPF Data Collection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503188
Recruitment Status : Completed
First Posted : April 19, 2018
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Device: Littmann ® Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 28, 2018
Actual Primary Completion Date : January 3, 2019
Actual Study Completion Date : January 3, 2019


Arm Intervention/treatment
Experimental: All participants Device: Littmann ®
electronic stethoscope




Primary Outcome Measures :
  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 Outcome Measures :
  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;

    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.

  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".



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503188


Locations
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Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09116
Fachkrankenhaus Coswig GmbH
Coswig, Germany, 01640
Klinik Donaustauf
Donaustauf, Germany, 93093
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany, 45239
Universitätsklinikum Gießen und Marburg GmbH
Gießen, Germany, 35392
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, Germany, 69126
Klinikum Konstanz
Konstanz, Germany, 78464
Krankenhaus Bethanien gGmbH
Solingen, Germany, 42699
Sponsors and Collaborators
Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] October 17, 2018
Statistical Analysis Plan  [PDF] July 26, 2018

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03503188    
Other Study ID Numbers: 0352-2119
First Posted: April 19, 2018    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial