Interstitial Lung DiseaseNCT02636452
Cardiopulmonary Exercise Testing in Interstitial Lung Disease
An observational study of Interstitial Lung Disease, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom. Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- cardiopulmonary exercise test
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 31 Oct 2013to 30 Sep 2017
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Interstitial lung diseases
Who may be able to join
- informed consent provided
- ILD
Who cannot join
- no informed consent
- no ILD
Trial locations and contacts
1 site in 1 country.
Germany1 site
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine
Solingen, North Rhine-Westphalia, 42699
About this study
In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom. Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD.
- Conditions
- Interstitial Lung Disease
- Being tested
- cardiopulmonary exercise test
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary exercise testOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar-arterial oxygen partial pressure difference (AaDO2) in cardipulmonary exercise testing in ILD
Measured: quarterly, three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study start31 Oct 2013
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636452
- Sponsor's protocol ID
- 80/2013
- Status last verified
- Oct 2018
- First submitted
- 9 Nov 2015
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Fischer A, West SG, Swigris JJ, Brown KK, du Bois RM. Connective tissue disease-associated interstitial lung disease: a call for clarification. Chest. 2010 Aug;138(2):251-6. doi: 10.1378/chest.10-0194.
PubMed 20682528Fell CD, Liu LX, Motika C, Kazerooni EA, Gross BH, Travis WD, Colby TV, Murray S, Toews GB, Martinez FJ, Flaherty KR. The prognostic value of cardiopulmonary exercise testing in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2009 Mar 1;179(5):402-7. doi: 10.1164/rccm.200802-241OC. Epub 2008 Dec 12.
PubMed 19074597Hagmeyer L, Herkenrath S, Anduleit N, Treml M, Randerath W. Cardiopulmonary Exercise Testing Allows Discrimination Between Idiopathic Non-specific Interstitial Pneumonia and Idiopathic Pulmonary Fibrosis in Mild to Moderate Stages of the Disease. Lung. 2019 Dec;197(6):721-726. doi: 10.1007/s00408-019-00282-9. Epub 2019 Nov 1.
PubMed 31676976
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Testing in Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02636452
- Acronym / sponsor ID
- 80/2013
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 31 Oct 2013 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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.
In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom. Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Interstitial lung diseases
Key inclusion criteria (2 listed)
- informed consent provided
- ILD
Key exclusion criteria (2 listed)
- no informed consent
- no ILD
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 |
|---|---|---|
| cardiopulmonary exercise test | Other | – |
Primary outcome
Alveolar-arterial oxygen partial pressure difference (AaDO2) in cardipulmonary exercise testing in ILD
Time frame: quarterly, three years
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 29 Oct 2018.
- Results publication: PubMed 20682528Fischer A, West SG, Swigris JJ, Brown KK, du Bois RM. Connective tissue disease-associated interstitial lung disease: a call for clarification. Chest. 2010 Aug;138(2):251-6. doi: 10.1378/chest.10-0194.
- Results publication: PubMed 19074597Fell CD, Liu LX, Motika C, Kazerooni EA, Gross BH, Travis WD, Colby TV, Murray S, Toews GB, Martinez FJ, Flaherty KR. The prognostic value of cardiopulmonary exercise testing in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2009 Mar 1;179(5):402-7. doi: 10.1164/rccm.200802-241OC. Epub 2008 Dec 12.
- Derived from this study: PubMed 31676976Hagmeyer L, Herkenrath S, Anduleit N, Treml M, Randerath W. Cardiopulmonary Exercise Testing Allows Discrimination Between Idiopathic Non-specific Interstitial Pneumonia and Idiopathic Pulmonary Fibrosis in Mild to Moderate Stages of the Disease. Lung. 2019 Dec;197(6):721-726. doi: 10.1007/s00408-019-00282-9. Epub 2019 Nov 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Wissenschaftliches Institut Bethanien e.V at 1 site 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 2 inclusion and 2 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Alveolar-arterial oxygen partial pressure difference (AaDO2) in cardipulmonary exercise testing in ILD (time frame: quarterly, three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02636452, which also lists 3 linked publications.
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 29 Oct 2018.