NCT03503188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

March 27, 2018

Results QC Date

December 20, 2019

Last Update Submit

January 14, 2020

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale

    Day 1 (Visit 1)

  • Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum

    Day 1 (Visit 1)

  • Entire Study - Smoking Status

    Day 1 (Visit 1)

  • Entire Study - Body Mass Index (BMI)

    Day 1 (Visit 1)

  • Sub Study - The Percentage of Collected Auscultation Points

    Day 1 (Visit 1)

Study Arms (1)

All participants

EXPERIMENTAL
Device: Littmann ®

Interventions

Littmann ®DEVICE

electronic stethoscope

All participants

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Fachkrankenhaus Coswig GmbH

Coswig, 01640, Germany

Location

Klinik Donaustauf

Donaustauf, 93093, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, 35392, Germany

Location

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Klinikum Konstanz

Konstanz, 78464, Germany

Location

Krankenhaus Bethanien gGmbH

Solingen, 42699, Germany

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Boehringer Ingelheim, Call Centre
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 19, 2018

Study Start

March 28, 2018

Primary Completion

January 3, 2019

Study Completion

January 3, 2019

Last Updated

January 27, 2020

Results First Posted

January 27, 2020

Record last verified: 2020-01

Locations

DE(10)