Clinical trial NCT03979430: Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study
Official title: Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Exacerbation
Idiopathic Pulmonary Fibrosis
Home Spirometry
Keywords: Acute Exacerbation
Idiopathic Pulmonary Fibrosis
Home Spirometry
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: University of Giessen
name: Hannover Medical School
name: Ludwig-Maximilians - University of Munich
name: LungenClinic Grosshansdorf
First posted: 2019-06-07
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention group on 5 different sites without a control group
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Correlation of change in FVC-values and the appearance of an acute exacerbation
timeFrame: Each participant will be followed for one year
Secondary outcomes:
measure: Correlation between spirometry and early detection of an acute exacerbation
timeFrame: 1 year
measure: Correlation between home spirometry and health related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University of Gießen-Marburg
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf
city: Hannover
country: Germany
facility: Medical University Hannover
city: München
country: Germany
facility: CPC Comprehensive Pneumology Center
Study officials:
affiliation: Heidelberg University
name: Michael Kreuter, Prof.
role: PRINCIPAL_INVESTIGATOR
References: