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

Phase

N/A

Condition

Cystic Fibrosis

Idiopathic Pulmonary Fibrosis

Lung Injury

Treatment

N/A

Clinical Study ID

NCT03979430

AE-IPF study

Ages 18-85
All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Ability to understand the study
diagnosis of IPF
Age > 18 years
FVC < 70%
DLCO-SB <60%
Ability to work with a tablet and home spirometer

Exclusion

Exclusion Criteria:

Patient does not understand the study
Patient cannot participate in study related processes
pulmonary infection within the last 4 weeks
acute exacerbation within the last 4 weeks
obstructive Ventilation disorders
other respiratory decline within the last 4 weeks
relevant malignancy within the last 5 years

Study Design

September 07, 2018

December 31, 2020

Study Description

This study is a multi-Center study happening on five different sites, Heidelberg, Gießen, Grosshansdorf, München, and Hannover, all in Germany. Each site recuits ten patients for a total of 50 patients.

All 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 and data will be transferred to a webpage after the measurement, that team members have access to the data and can see the progress daily. 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.

In addition to the home spirometry, patients will conduct a survey to measure health related quality of life (K-BILD). This questionnaire will be conducted at baseline and then every 12 weeks. Every 4 weeks the patients are participating in a phone interview to record changes in medication and condition. 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 a urine sample will be collected and analyzed.

Aim is to detect and treat an acute exacerbation early.

Connect with a study center

University of Gießen-Marburg
Gießen,
Germany
Site Not Available
LungenClinic Grosshansdorf
Grosshansdorf,
Germany
Site Not Available
Medical University Hannover
Hannover,
Germany
Site Not Available
CPC Comprehensive Pneumology Center
München,
Germany
Site Not Available

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