NCT01327248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 27, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

March 30, 2011

Last Update Submit

June 26, 2012

Conditions

Bronchiolitis Obliterans

Keywords

Bronchiolitis obliteransHRCTSputumBloodInflammationadaptive immune systeminnate immune system

Study Arms (2)

affected patients

20 Patients suffering from bronchiolitis obliterans

non-affected patients

20 matched controls not suffering from bronchiolitis obliterans

Eligibility Criteria

Age6 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital, Goethe-University

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (4)

  • Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. doi: 10.1002/ppul.20145.

    PMID: 15635614BACKGROUND

  • 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. doi: 10.1002/ppul.1145.

    PMID: 11596161BACKGROUND

  • Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9. doi: 10.1080/080352500300002633.

    PMID: 11106056BACKGROUND

  • 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. doi: 10.1164/rccm.200212-1424BC. Epub 2003 Apr 2.

    PMID: 12672648BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, and Sputum

MeSH Terms

Conditions

Bronchiolitis ObliteransInflammation

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Rosewich, MD

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Martin Rosewich, MD

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 1, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

June 27, 2012

Record last verified: 2012-06

Locations

DE(1)