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

Not Applicable

Completed

• Conditions: Acute Exacerbation; Home Spirometry; Idiopathic Pulmonary Fibrosis
• Interventions: Other: Home spirometry

• Registration Number: NCT03979430
• Lead Sponsor: Heidelberg University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-09-07
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Home spirometry	There is only one arm with the intervention.

Primary Outcome Measures

Name	Time	Method
Correlation of change in FVC-values and the appearance of an acute exacerbation	Each participant will be followed for one year	A decrease in FVC value can predict an acute exacerbation. Through daily home spirometry, study team members have access to measured FVC-values from each patient. Therefore, changes in FVC values can be seen directly and actions can be taken to detect an acute exacerbation or even to avoid one.

Secondary Outcome Measures

Name	Time	Method
Correlation between spirometry and early detection of an acute exacerbation	1 year	Identifying an acute exacerbation early is important for further treatment of ILD patients. With home spirometry, the investigators want to examine the feasibility of such measurements.
Correlation between home spirometry and health related quality of life	1 year

Trial Locations

Locations (4)

University of Gießen-Marburg; 🇩🇪 Gießen, Germany

LungenClinic Grosshansdorf; 🇩🇪 Grosshansdorf, Germany

Medical University Hannover; 🇩🇪 Hannover, Germany

CPC Comprehensive Pneumology Center; 🇩🇪 München, Germany