Digital Auscultation Test - IPF Data Collection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-28

Study Completion Date

2019-01-03

Brief Summary

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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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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All participants

Group Type EXPERIMENTAL

Littmann ®

Intervention Type DEVICE

electronic stethoscope

Interventions

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Littmann ®

electronic stethoscope

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No