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

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ClinicalTrials.gov Identifier: NCT01327248
Recruitment Status : Completed
First Posted : April 1, 2011
Last Update Posted : June 27, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals

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
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 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 2011
Primary Completion Date : May 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
affected patients
20 Patients suffering from bronchiolitis obliterans
non-affected patients
20 matched controls not suffering from bronchiolitis obliterans



Biospecimen Retention:   Samples With DNA
whole blood, serum, and Sputum


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327248


Locations
Germany
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

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
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: June 27, 2012
Last Verified: June 2012

Keywords provided by Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals:
Bronchiolitis obliterans
HRCT
Sputum
Blood
Inflammation
adaptive immune system
innate immune system

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