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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979430
• Other study ID #: AE-IPF study
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation
• Fibrosis
• Home Spirometry
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Gießen-Marburg	Gießen
Germany	LungenClinic Grosshansdorf	Grosshansdorf
Germany	Medical University Hannover	Hannover
Germany	CPC Comprehensive Pneumology Center	München

Sponsors (5)

Lead Sponsor	Collaborator
Heidelberg University	Hannover Medical School, Ludwig-Maximilians - University of Munich, LungenClinic Grosshansdorf, University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of change in FVC-values and the appearance of an acute exacerbation	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.	Each participant will be followed for one year
Secondary	Correlation between spirometry and early detection of an acute exacerbation	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.	1 year
Secondary	Correlation between home spirometry and health related quality of life		1 year