LCI and Bronchial Inflammation in Patients With BO

Bronchiolitis Obliterans Clinical Trial

— FRABO-02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495597
• Other study ID #: EC 124/13
• Status: Completed
• Phase: N/A
• First received: July 6, 2015
• Last updated: July 22, 2015
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 28 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Inflammation

Intervention

Other:
• no intervention - just observational

Locations

Country	Name	City	State
Germany	Children's Hospital, Goethe-University	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LCI compared to RV/TLC%-pred.	Correlation of these lung function Parameters in patients with BO compared to healthy controls	during Visit 1 (single day, single observation)	No
Secondary	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	during Visit 1 (single day, single observation)	No
Secondary	Comparison of low CrP	serum parameter for systemic inflammation	during Visit 1 (single day, single observation)	No
Secondary	FVC (%-pred.)	To compare FVC (%-pred.)of patients suffering from BO with FVC (%-pred.)of a healthy control group	during Visit 1 (single day, single observation)	No
Secondary	FEV1 (%-pred.)	To compare FEV1 (%-pred.)of patients suffering from BO withFEV1 (%-pred.)of a healthy control group	during Visit 1 (single day, single observation)	No
Secondary	Tiffeneau-Index	To compare Tiffeneau-Index of patients suffering from BO with Tiffeneau-Index of a healthy control group	during Visit 1 (single day, single observation)	No
Secondary	sRtot (%-pred.)	To compare sRtot (%-pred.) of patients suffering from BO with sRtot (%-pred.) of a healthy control group	during Visit 1 (single day, single observation)	No
Secondary	RV/TLC (%-pred.)	To compare RV/TLC (%-pred.) of patients suffering from BO with RV/TLC (%-pred.) of a healthy control group	during Visit 1 (single day, single observation)	No
Secondary	IL-6 (pg/ml)	comparing IL-6 in Serum of patients with BO with healthy controls	during Visit 1 (single day, single observation)	No
Secondary	IL-8 (pg/ml)	comparing IL-8 in Serum of patients with BO with healthy controls	during Visit 1 (single day, single observation)1	No
Secondary	IL-17 (pg/ml)	comparing IL-17 in Serum of patients with BO with healthy controls	during Visit 1 (single day, single observation)	No
Secondary	IL-6 (mRNA delta-delta-ct)	compare IL-6 mRNA in Sputum cells of patients with BO with healthy controls	during Visit 1 (single day, single observation)	No
Secondary	IL-8 (mRNA delta-delta-ct)	compare IL-8 mRNA in Sputum cells of patients with BO with healthy controls	during Visit 1	No
Secondary	IL-17 (mRNA delta-delta-ct)	compare IL-17 mRNA in Sputum cells of patients with BO with healthy controls	during Visit 1 (single day, single observation)	No
Secondary	Percentage of FOXP3 positive cells in Sputum	compare percentage of FOXP3 positive cells in Sputum cells of patients with BO with healthy controls	during Visit 1 (single day, single observation)	No

External Links

•   Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review
•   Pichler M, Herrmann G, Schmidt H, Ahrens P, Zielen S. Persistent adenoviral infection and chronic obstructive bronchitis in children: is there a link? Pediatr Pulmonol. 2001 Nov;32(5):367-71.
•   Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9.
•   Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3.