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Digital Auscultation Test - IPF Data Collection

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 45 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female patients - Age ≥ 45 years at the day of the study visit - Diagnosis: - For patients with confirmed IPF diagnosis - a clinical diagnosis of IPF within the last 24 months from the day of the study visit, according to the ATS/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 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03503188
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Klinikum Chemnitz gGmbH, Chemnitz, Germany

Status

Completed

Address

Klinikum Chemnitz gGmbH

Chemnitz, , 09116

Fachkrankenhaus Coswig GmbH, Coswig, Germany

Status

Recruiting

Address

Fachkrankenhaus Coswig GmbH

Coswig, , 01640

Klinik Donaustauf, Donaustauf, Germany

Status

Completed

Address

Klinik Donaustauf

Donaustauf, , 93093

Essen, Germany

Status

Completed

Address

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, , 45239

Gießen, Germany

Status

Recruiting

Address

Universitätsklinikum Gießen und Marburg GmbH

Gießen, , 35392

Großhansdorf, Germany

Status

Recruiting

Address

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, , 22927

Site Contact

Anne-Marie Kirsten

a.kirsten@pulmoresearch.de

+49 (4102) 8881109

Medizinische Hochschule Hannover, Hannover, Germany

Status

Recruiting

Address

Medizinische Hochschule Hannover

Hannover, , 30625

Heidelberg, Germany

Status

Recruiting

Address

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, , 69126

Site Contact

Michael Kreuter

kreuter@uni-heidelberg.de

+49 (6221) 3961201

Klinikum Konstanz, Konstanz, Germany

Status

Recruiting

Address

Klinikum Konstanz

Konstanz, , 78464

Krankenhaus Bethanien gGmbH, Solingen, Germany

Status

Completed

Address

Krankenhaus Bethanien gGmbH

Solingen, , 42699