FRABO-02: Bronchial Inflammation in Patients With Bronchiolithis Obliterans

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01633385
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans

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

Study Design

• Study Type: Observational
• Actual Enrollment: 37 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Lung Function and Bronchial Inflammation in Patients With Bronchiolithis Obliterans
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Subject-Group Patients suffering from doctors diagnosed bronchiolitis obliterans
Control Group age- and sex matched to subject-group

Outcome Measures

Primary Outcome Measures

1. Change of FEF75 over time [V1: Day 1 - V2: Day 28-42]

   Look for changes/ variability of this lung function parameter

Secondary Outcome Measures

1. change of sputum cell count over time [V1: Day 1 - V2: Day 28-42]

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

2. change of low CrP over time [V1: Day 1 - V2: Day 28-42]

   serum parameter for systemic inflammation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital, Goethe-University	Frankfurt am Main	Hessen	Germany	60590

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review
• Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3.
• 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.

Publications

None provided.

• Responsible Party: Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT01633385
• Other Study ID Numbers: BO2012-02
• First Posted: Jul 4, 2012
• Last Update Posted: Apr 4, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University Hospital: bronchial inflammation; Bronchiolitis obliterans; Sputum; Blood; Inflammation; adaptive immune system; innate immune system
• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Inflammation

Study Results

No Results Posted as of Apr 4, 2013