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Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans (Frabo)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01327248
First received: March 30, 2011
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Bronchiolitis Obliterans

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Biospecimen Retention:   Samples With DNA

whole blood, serum, and Sputum


Enrollment: 40
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
affected patients
20 Patients suffering from bronchiolitis obliterans
non-affected patients
20 matched controls not suffering from 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.

  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study is carried out in children and young adults (6 to 25 years). Both the patients (20) and the healthy subjects (20) are recruited from the outpatient clinic of the departement of Pediatric Allergy and Pulmonology, University Clinic, JW Goethe University, Frankfurt/M, Germany.

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:

  • <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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327248

Locations
Germany
Children's Hospital, Goethe-University
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Martin Rosewich, MD Goethe University
  More Information

Publications:

Responsible Party: Dr. med. Martin Rosewich, Martin Rosewich, MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01327248     History of Changes
Other Study ID Numbers: FRA-BO
Study First Received: March 30, 2011
Last Updated: June 26, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Bronchiolitis obliterans
HRCT
Sputum
Blood
 Inflammation
adaptive immune system
innate immune system

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Inflammation
Bronchitis
Bronchial Diseases
 Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013