Acute ExacerbationNCT03979430
Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study
A study testing Home spirometry in people with Acute Exacerbation and Idiopathic Pulmonary Fibrosis, run by Heidelberg University at 4 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Exacerbation, Idiopathic Pulmonary Fibrosis, Home Spirometry
- What is being tested?
- Home spirometry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesGermany
- Study dates
- 7 Sep 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Germany4 sites
University of Gießen-Marburg
Giessen
LungenClinic Grosshansdorf
Großhansdorf
Medical University Hannover
Hanover
CPC Comprehensive Pneumology Center
München
About this study
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.
Read the 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.
- Being tested
- Home spirometry
- Keywords
- Acute Exacerbation, Idiopathic Pulmonary Fibrosis, Home Spirometry
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home spirometryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | There is only one arm with the intervention. Receives: Other: Home spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each participant will be followed for one year
Secondary outcomes (2)
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.
Measured: 1 year
Correlation between home spirometry and health related quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start7 Sep 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention group on 5 different sites without a control group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Giessen, Hannover Medical School, Ludwig-Maximilians - University of Munich, LungenClinic Grosshansdorf
- Responsible party
- Principal investigator, Michael Kreuter, Heidelberg University
- Investigators
- Michael Kreuter, Prof., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979430
- Sponsor's protocol ID
- AE-IPF study
- Status last verified
- Oct 2021
- First submitted
- 14 May 2019
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study
- ClinicalTrials.gov ID
- NCT03979430
- Acronym / sponsor ID
- AE-IPF study
- Keywords
- Acute Exacerbation, Idiopathic Pulmonary Fibrosis, Home Spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- University of Giessen, Hannover Medical School, Ludwig-Maximilians - University of Munich, LungenClinic Grosshansdorf
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention group on 5 different sites without a control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Home spirometryThere is only one arm with the intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand the study
- diagnosis of IPF
- Age > 18 years
- FVC < 70%
- DLCO-SB <60%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home spirometryPatients 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. | Other | Intervention |
Primary outcome
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.
2 secondary outcomes
Correlation between spirometry and early detection of an acute exacerbation
Time frame: 1 year
Correlation between home spirometry and health related quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kreuter, Prof. principal investigator
Heidelberg University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home spirometry in people with Acute Exacerbation and Idiopathic Pulmonary Fibrosis, run by Heidelberg University at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of change in FVC-values and the appearance of an acute exacerbation (time frame: Each participant will be followed for one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.