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

NCT03979430 | Completed

• 1 other identifier: AE-IPF study
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Exacerbation; Idiopathic Pulmonary Fibrosis; Home Spirometry

Keywords

Acute Exacerbation; Idiopathic Pulmonary Fibrosis; Home Spirometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation between spirometry and early detection of an acute exacerbation

  1 year

• Correlation between home spirometry and health related quality of life

  1 year

Study Arms (1)

Intervention

OTHER

There is only one arm with the intervention.

Other: Home spirometry

Interventions

Home spirometry OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• University of Giessen: collaborator
• Hannover Medical School: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• LungenClinic Grosshansdorf: collaborator

Study Sites (4)

University of Gießen-Marburg

Giessen, Germany

Location

LungenClinic Grosshansdorf

Großhansdorf, Germany

Location

Medical University Hannover

Hanover, Germany

Location

CPC Comprehensive Pneumology Center

München, Germany

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Kreuter, Prof.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group on 5 different sites without a control group

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: June 7, 2019
• Study Start: September 7, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)