Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study

Summary

Idiopathic pulmonary fibrosis (IPF) is a chronic disease, leading to poor lung function with a median survival of 2-3 years. Acute exacerbation of idiopathic IPF is a complication associated with a mortality rate \> 50%. So far, the appearance of an acute exacerbation is unpredictable. Worsening of the IPF accompanies with a decrease of the FVC-value, the lung capacity. So far, studies are missing investigating the correlation between a decrease of the FVC-value and emerging acute exacerbations. Therefore, this study uses daily home spirometry to investigate that correlation. With this study the investigators hope to determine acute exacerbations early and treat patients early.

Conditions

• Acute Exacerbation
• Idiopathic Pulmonary Fibrosis
• Home Spirometry

Interventions

OTHER

Home spirometry

Patients will receive a tablet and a spirometer for daily home spirometry. Each patient is supposed to do the home spirometry at the same time every morning. The spirometer and the tablet are connected via Bluetooth. Data will be transferred to a webpage, which team members have access to. Alerts will be automatically send to team members, if the FVC-value decreases about 5% or more within three consecutive days or if the patient does not do the measurement on three consecutive days. Study period is one year. Patients will also conduct a survey to measure health related quality of life (K-BILD). This questionnaire, as well as a phone interview to record changes in medication and condition will be conducted at baseline and every 4 weeks. At baseline and after 3, 6, 9, and 12 months, patients will conduct a 6 minutes walking test, lung function test, blood will be drawn for biomarker analysis, and sputum, nasal swab, and urine samples will be collected and analyzed.

Sponsors & Collaborators

• University of Giessen

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• LungenClinic Grosshansdorf

  collaborator OTHER

• Heidelberg University

  lead OTHER

Principal Investigators

• Michael Kreuter, Prof. · Heidelberg University

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-07

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Germany

Study Locations