Frabo: Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01327248
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

The aim of this case-control study is the characterization of the bronchial and systemic inflammation of children and young adults with bronchiolitis obliterans.

On the first visit subjects are asked to perform a lung function test (spirometry, body plethysmography with helium). Further levels of eNO and eCO are determined. A blood sample is drawn to describe the inflammatory status. Bronchial inflammation will be measured in induced sputum. At the second visit, a non-specific bronchial provocation testing (PD20 FEV1 methacholine) is performed.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans

Detailed Description

Objectives:

The aim of this study is the characterization of patients with bronchiolitis obliterans in terms of lung function, bronchial hyperreactivity and the degree of the systemic and bronchial inflammation.

Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. In the conduct of this study the investigators will retrospectively and systematically evaluate the available high-resolution computed tomography (HRCT) studies of affected patients

Methods and Work Programme:

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

V1:

• Measurement of nitric oxide in expired air (eNO)

• Measurement of carbon monoxide in the exhaled air (eCO)

• 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:

• Unspecific bronchial provocation test with methacholine (PD20 FEV1 methacholine)

Study population:

Children and young people (6 - 25 years of age). Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
affected patients 20 Patients suffering from bronchiolitis obliterans
non-affected patients 20 matched controls not suffering from bronchiolitis obliterans

Outcome Measures

Primary Outcome Measures

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:

• <6 and > 25 years of age on the day of written informed consent

• 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

• Principal Investigator: Martin Rosewich, MD, Goethe University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gerhardt SG, McDyer JF, Girgis RE, Conte JV, Yang SC, Orens JB. Maintenance azithromycin therapy for bronchiolitis obliterans syndrome: results of a pilot study. Am J Respir Crit Care Med. 2003 Jul 1;168(1):121-5. Epub 2003 Apr 2.
• 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.

• Responsible Party: Dr. med. Martin Rosewich, Martin Rosewich, MD, Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT01327248
• Other Study ID Numbers: FRA-BO
• First Posted: Apr 1, 2011
• Last Update Posted: Jun 27, 2012
• Last Verified: Jun 1, 2012

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

Study Results

No Results Posted as of Jun 27, 2012