Bronchial Inflammation in Patients With Bronchiolithis Obliterans

Bronchiolitis Obliterans Clinical Trial

— FRABO-02  

Official title:

Lung Function and Bronchial Inflammation in Patients With Bronchiolithis Obliterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633385
• Other study ID #: BO2012-02
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: April 3, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• 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 plan to study the variability of lung function parameters and bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with TLCO), and measure the fraction of exhaled nitric oxide (eNO). Further a blood sample is drawn to determine the systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This investigation will be repeated after 4-6 weeks. The aim of this study is to define baseline values and the variability of possible outcome parameters for future interventional studies.

Description:

The purpose of this study is to characterize the variability of lung function values and bronchial inflammation of 20 Patients with Bronchiolitis obliterans aged between 6 up to 25 years. The patients' data will be compared with the results of 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:

This study consists of two study visits (V1 and V2)

V1:

• Measurement of nitric oxide in expired air (eNO)

• Lung function testing with spirometry and body plethysmography

• Bronchodilation

• Lung function testing with spirometry and body plethysmography

• 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

V2:

• Measurement of nitric oxide in expired air (eNO)

• Lung function testing with spirometry and body plethysmography

• Bronchodilation

• Lung function testing with spirometry and body plethysmography

• Induced sputum for inflammatory mediators and microbiological investigations

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 25 Years

Eligibility

Inclusion Criteria:

• informed consent

• between 6 and 25 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

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	Change of FEF75 over time	Look for changes/ variability of this lung function parameter	V1: Day 1 - V2: Day 28-42	No
Secondary	change of sputum cell count over time	induced sputum will be analyzed for different cellular components such as alveolar macrophages, neutrophils, lymphocytes and others. Epithelial cells will be excluded	V1: Day 1 - V2: Day 28-42	No
Secondary	change of low CrP over time	serum parameter for systemic inflammation	V1: Day 1 - V2: Day 28-42	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.