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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03979430
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Heidelberg University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Kreuter, Prof.
Principal Investigator Affiliation Heidelberg University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOther
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Exacerbation, Idiopathic Pulmonary Fibrosis, Home Spirometry
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CPC Comprehensive Pneumology Center, München, Germany

Status

Recruiting

Address

CPC Comprehensive Pneumology Center

München, ,

Site Contact

Jürgen Behr, Prof.

kreuter@uni-heidelberg.de

089 3187 #1889

Medical University Hannover, Hannover, Germany

Status

Recruiting

Address

Medical University Hannover

Hannover, ,

Site Contact

Antje Prasse, Prof.

Prasse.Antje@mh-hannover.de

+49 511 532 #3536

LungenClinic Grosshansdorf, Grosshansdorf, Germany

Status

Recruiting

Address

LungenClinic Grosshansdorf

Grosshansdorf, ,

Site Contact

Heike Biller, Dr.

h.biller@lungenclinic.de

+49 4102-601 #2414

University of Gießen-Marburg, Gießen, Germany

Status

Recruiting

Address

University of Gießen-Marburg

Gießen, ,

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

Back to Top
footer_txt_bblBook a PFF Ambassador for your event.   Call 844.TalkPFF >