Bronchial Inflammation in Patients With Bronchiolithis Obliterans

NCT ID: NCT01633385

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-12-31

Brief 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.

Detailed 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

Conditions

Bronchiolitis Obliterans

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Subject-Group

Patients suffering from doctors diagnosed bronchiolitis obliterans

No interventions assigned to this group

Control Group

age- and sex matched to subject-group

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Martin Rosewich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital, Goethe-University

Frankfurt am Main, Hesse, Germany

Countries

Germany

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/15635614

Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review

http://www.ncbi.nlm.nih.gov/pubmed/16738042

Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3.

http://www.ncbi.nlm.nih.gov/pubmed/11596161

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.

http://www.ncbi.nlm.nih.gov/pubmed/11106056

Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9.

Other Identifiers

BO2012-02

Identifier Type: -

Identifier Source: org_study_id