Digital Auscultation Test - IPF Data Collection

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503188
• Other study ID #: 0352-2119
• Status: Completed
• Phase: Phase 4
• Start date: March 28, 2018
• Est. completion date: January 3, 2019

Study information

• Verified date: January 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: January 3, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Device:
• Littmann ®
electronic stethoscope

Locations

Country	Name	City	State
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Fachkrankenhaus Coswig GmbH	Coswig
Germany	Klinik Donaustauf	Donaustauf
Germany	Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH	Essen
Germany	Universitätsklinikum Gießen und Marburg GmbH	Gießen
Germany	Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH	Großhansdorf
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg	Heidelberg
Germany	Klinikum Konstanz	Konstanz
Germany	Krankenhaus Bethanien gGmbH	Solingen

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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".	Day 1 (Visit 1)
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; = 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)
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.	Day 1 (Visit 1)
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).	Day 1 (Visit 1)
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).	Day 1 (Visit 1)
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".	Day 1 (Visit 1)

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