Clinical trial NCT03503188: Digital Auscultation Test - IPF Data Collection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-04-19
Enrollment: 274
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Main Study - The Percentage of Collected Auscultation Points
timeFrame: Day 1 (Visit 1)
Secondary outcomes:
measure: Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale
timeFrame: Day 1 (Visit 1)
measure: Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum
timeFrame: Day 1 (Visit 1)
measure: Entire Study - Smoking Status
timeFrame: Day 1 (Visit 1)
measure: Entire Study - Body Mass Index (BMI)
timeFrame: Day 1 (Visit 1)
measure: Sub Study - The Percentage of Collected Auscultation Points
timeFrame: Day 1 (Visit 1)
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig GmbH
city: Donaustauf
country: Germany
facility: Klinik Donaustauf
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: Solingen
country: Germany
facility: Krankenhaus Bethanien gGmbH
Study officials:
References: