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Bronchiolitis ObliteransFRABO-02NCT02495597

LCI and Bronchial Inflammation in Patients With BO

An observational study of Bronchiolitis Obliterans, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) . Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group. Read more about this study

Who is it for?
Ages 6 to 28 yearsHealthy volunteers can take part
Conditions the study is for
Bronchiolitis Obliterans
How many people
37 participants
Where
1 siteGermany
Study dates
Apr 2013to Dec 2014
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 6 to 28 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Patients suffering from Bronchiolitis obliterans and controls

Who may be able to join

  • informed consent
  • between 6 and 28 years of age
  • Known Bronchiolitis obliterans
  • no Bronchiolitis obliterans(depending on the study group)
  • Ability to perform lung function tests and inhalation

Who cannot join

  • Acute illness with systemic or bronchial inflammation
  • every chronic condition or infection (eg HIV, tuberculosis, malignancy)
  • pregnancy
  • known alcohol and/ or drug abuse
  • Inability to understand the extent and scope of the study
  • Participation in another study

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Children's Hospital, Goethe-University

    Frankfurt am Main, Hesse, 60590

Other trials in Germany

About this study

Official title: Lung Clearance Index (LCI) and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (BO)

The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) . Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with DLCO) and compare the results with the LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood sample to determine the level of systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This study will set baseline markers for future interventional studies.

Read the detailed description

The purpose of this study is to compare lung function values with the Lung clearance index of 20 Patients with Bronchiolitis obliterans aged between 6 up to 28 years. Further we aim to compare the bronchial Inflammation between the patients and a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies.

The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.

(Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)

Methods and Work Programme:

  • Measurement of nitric oxide in expired air (FeNO)
  • Lung function testing with spirometry and body plethysmography
  • Lung clearance index (LCI)
  • Bronchodilation
  • Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system)
  • Induced sputum for inflammatory mediators and microbiological investigations
Being tested
no intervention - just observational
Keywords
bronchial inflammation, Bronchiolitis obliterans, Sputum, Blood, Inflammation, adaptive immune system, innate immune system
Medical subject headings
Bronchiolitis Obliterans, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no intervention - just observationalOther

Study groups in NCT02495597
Study groupRoleWhat they receive
Subject-GroupPatients suffering from doctors diagnosed bronchiolitis obliterans
Receives: Other: no intervention - just observational
Control Groupage- and sex matched to subject-group
Receives: Other: no intervention - just observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LCI compared to RV/TLC%-pred.

    Correlation of these lung function Parameters in patients with BO compared to healthy controls

    Measured: during Visit 1 (single day, single observation)

Secondary outcomes (14)

  1. change of sputum cell count over time (percentage of neutrophils)

    induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others. Epithelial cells will be excluded

    Measured: during Visit 1 (single day, single observation)

  2. Comparison of low CrP

    serum parameter for systemic inflammation

    Measured: during Visit 1 (single day, single observation)

  3. FVC (%-pred.)

    To compare FVC (%-pred.)of patients suffering from BO with FVC (%-pred.)of a healthy control group

    Measured: during Visit 1 (single day, single observation)

  4. FEV1 (%-pred.)

    To compare FEV1 (%-pred.)of patients suffering from BO withFEV1 (%-pred.)of a healthy control group

    Measured: during Visit 1 (single day, single observation)

  5. Tiffeneau-Index

    To compare Tiffeneau-Index of patients suffering from BO with Tiffeneau-Index of a healthy control group

    Measured: during Visit 1 (single day, single observation)

  6. sRtot (%-pred.)

    To compare sRtot (%-pred.) of patients suffering from BO with sRtot (%-pred.) of a healthy control group

    Measured: during Visit 1 (single day, single observation)

  7. RV/TLC (%-pred.)

    To compare RV/TLC (%-pred.) of patients suffering from BO with RV/TLC (%-pred.) of a healthy control group

    Measured: during Visit 1 (single day, single observation)

  8. IL-6 (pg/ml)

    comparing IL-6 in Serum of patients with BO with healthy controls

    Measured: during Visit 1 (single day, single observation)

  9. IL-8 (pg/ml)

    comparing IL-8 in Serum of patients with BO with healthy controls

    Measured: during Visit 1 (single day, single observation)1

  10. IL-17 (pg/ml)

    comparing IL-17 in Serum of patients with BO with healthy controls

    Measured: during Visit 1 (single day, single observation)

  11. IL-6 (mRNA delta-delta-ct)

    compare IL-6 mRNA in Sputum cells of patients with BO with healthy controls

    Measured: during Visit 1 (single day, single observation)

  12. IL-8 (mRNA delta-delta-ct)

    compare IL-8 mRNA in Sputum cells of patients with BO with healthy controls

    Measured: during Visit 1

  13. IL-17 (mRNA delta-delta-ct)

    compare IL-17 mRNA in Sputum cells of patients with BO with healthy controls

    Measured: during Visit 1 (single day, single observation)

  14. Percentage of FOXP3 positive cells in Sputum

    compare percentage of FOXP3 positive cells in Sputum cells of patients with BO with healthy controls

    Measured: during Visit 1 (single day, single observation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2013
  4. Study completionDec 2014

Resources

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
Case-control
Time perspective
Prospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02495597
Sponsor's protocol ID
EC 124/13
Acronym
FRABO-02
Status last verified
Jul 2015
First submitted
6 Jul 2015
Last updated
23 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiolitis Obliterans, run by Johann Wolfgang Goethe University Hospital 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 5 inclusion and 6 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 23 Jul 2015. 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?

LCI compared to RV/TLC%-pred. (time frame: during Visit 1 (single day, single observation)). 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 NCT02495597.

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 23 Jul 2015.

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