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Digital Auscultation Test - IPF Data Collection

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 4

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Device: Littmann ®

Study type

Interventional

Funder types

Industry

Identifiers

NCT03503188
0352-2119

Details and patient eligibility

About

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.

Enrollment

274 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

274 participants in 1 patient group

All participants
Experimental group
Treatment:
Device: Littmann ®

Trial documents
2

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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