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Completed

NCT Number: NCT02495597

LCI and Bronchial Inflammation in Patients With 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.

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Key information

Conditions

Bronchiolitis Obliterans Bronchial Diseases Bronchiolitis Bronchitis Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

6 year–28 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital, Goethe-University

Frankfurt am Main, Hesse, 60590, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

no intervention - just observational

Other

Primary outcomes

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

    Time frame: during Visit 1 (single day, single observation)

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

Secondary outcomes

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

    Time frame: during Visit 1 (single day, single observation)

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

  2. Comparison of low CrP

    Time frame: during Visit 1 (single day, single observation)

    serum parameter for systemic inflammation

  3. FVC (%-pred.)

    Time frame: during Visit 1 (single day, single observation)

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

  4. FEV1 (%-pred.)

    Time frame: during Visit 1 (single day, single observation)

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

  5. Tiffeneau-Index

    Time frame: during Visit 1 (single day, single observation)

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

  6. sRtot (%-pred.)

    Time frame: during Visit 1 (single day, single observation)

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

  7. RV/TLC (%-pred.)

    Time frame: during Visit 1 (single day, single observation)

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

  8. IL-6 (pg/ml)

    Time frame: during Visit 1 (single day, single observation)

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

  9. IL-8 (pg/ml)

    Time frame: during Visit 1 (single day, single observation)1

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

  10. IL-17 (pg/ml)

    Time frame: during Visit 1 (single day, single observation)

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

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

    Time frame: during Visit 1 (single day, single observation)

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

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

    Time frame: during Visit 1

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

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

    Time frame: during Visit 1 (single day, single observation)

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

  14. Percentage of FOXP3 positive cells in Sputum

    Time frame: during Visit 1 (single day, single observation)

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

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Acronym: FRABO-02

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jul 13, 2015
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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