Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979430
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : October 27, 2021
Sponsor:
Collaborators:
University of Giessen
Hannover Medical School
Ludwig-Maximilians - University of Munich
LungenClinic Grosshansdorf
Information provided by (Responsible Party):
Michael Kreuter, 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.

Condition or disease Intervention/treatment Phase
Acute Exacerbation Idiopathic Pulmonary Fibrosis Home Spirometry Other: Home spirometry Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Intervention group on 5 different sites without a control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study
Actual Study Start Date : September 7, 2018
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020


Arm Intervention/treatment
Intervention
There is only one arm with the 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.




Primary Outcome Measures :
  1. Correlation of change in FVC-values and the appearance of an acute exacerbation [ Time Frame: 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 :
  1. Correlation between spirometry and early detection of an acute exacerbation [ Time Frame: 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.

  2. Correlation between home spirometry and health related quality of life [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979430


Locations
Layout table for location information
Germany
University of Gießen-Marburg
Gießen, Germany
LungenClinic Grosshansdorf
Grosshansdorf, Germany
Medical University Hannover
Hannover, Germany
CPC Comprehensive Pneumology Center
München, Germany
Sponsors and Collaborators
Heidelberg University
University of Giessen
Hannover Medical School
Ludwig-Maximilians - University of Munich
LungenClinic Grosshansdorf
Investigators
Layout table for investigator information
Principal Investigator: Michael Kreuter, Prof. Heidelberg University
Layout table for additonal information
Responsible Party: Michael Kreuter, Principal Investigator, Heidelberg University
ClinicalTrials.gov Identifier: NCT03979430    
Other Study ID Numbers: AE-IPF study
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Kreuter, Heidelberg University:
Acute Exacerbation
Idiopathic Pulmonary Fibrosis
Home Spirometry
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases