NCT02627833

Brief Summary

Bronchiolitis obliterans is a chronic disease in which a persistent inflammatory process leads to obliteration of the small airways. Pulmonary function tests (body plethysmography with DLCO, lung clearance index) are performed and the fraction of exhaled nitric oxide is measured. A blood test is following to determine the inflammatory status und collect miRNA. Induced Sputum will be obtained.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

December 9, 2015

Last Update Submit

December 9, 2015

Conditions

Bronchiolitis Obliterans

Keywords

induced Sputumlung clearance indexmiRNAinflammationchronic lung disease

Outcome Measures

Primary Outcomes (1)

  • miRNA Status

    Blood sample to determine candidate miRNA for Bronchiolitis obliterans

    single day observation

Other Outcomes (13)

  • Lung clearance index (LCI)

    single day observation

  • FVC [%-pred.]

    single day observation

  • FEV1 [%-pred.]

    single day observation

  • +10 more other outcomes

Study Arms (2)

Subject Group

Patients suffering from Bronchiolitis Obliterans

Other: observation

Control Group

Age and sex matched control group

Other: observation

Interventions

observationOTHER

Record lung function, Lung clearance index, inflammatory status

Control GroupSubject Group

Eligibility Criteria

Age6 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with the assured diagnose of Bronchiolitis Obliterans and controls without this disease.

You may qualify if:

  • informed consent
  • age between 6 an 35 years
  • known bronchiolitis obliterans (Group Bronchiolitis)/ no Bronchiolitis Obliterans (Group matched controls)
  • ability to perform lung function tests and inhale correctly

You may not qualify if:

  • \<6 years of age
  • \>35 years of age
  • acute systemic or bronchial inflammation
  • other chronic diseases or infection (e.g. HIV, Tbc, malignoma)
  • pregnancy
  • alcohol, drug or illegal drug abuse
  • disability to register the range and consequences of the study
  • actual 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

RECRUITING

Related Publications (6)

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

    PMID: 15635614BACKGROUND

  • Boehler A, Kesten S, Weder W, Speich R. Bronchiolitis obliterans after lung transplantation: a review. Chest. 1998 Nov;114(5):1411-26. doi: 10.1378/chest.114.5.1411. No abstract available.

    PMID: 9824023BACKGROUND

  • Moonnumakal SP, Fan LL. Bronchiolitis obliterans in children. Curr Opin Pediatr. 2008 Jun;20(3):272-8. doi: 10.1097/MOP.0b013e3282ff62e9.

    PMID: 18475095BACKGROUND

  • 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: 11596161RESULT

  • Rosewich M, Zissler UM, Kheiri T, Voss S, Eickmeier O, Schulze J, Herrmann E, Ducker RP, Schubert R, Zielen S. Airway inflammation in children and adolescents with bronchiolitis obliterans. Cytokine. 2015 May;73(1):156-62. doi: 10.1016/j.cyto.2014.10.026. Epub 2015 Mar 6.

    PMID: 25748838RESULT

  • Motameny S, Wolters S, Nurnberg P, Schumacher B. Next Generation Sequencing of miRNAs - Strategies, Resources and Methods. Genes (Basel). 2010 Jun 3;1(1):70-84. doi: 10.3390/genes1010070.

    PMID: 24710011RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Cells of induced Sputum, blood sample

MeSH Terms

Conditions

Bronchiolitis ObliteransInflammation

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Martin Rosewich, MD

    Johann Wolfgang Goethe University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Rosewich, MD

CONTACT

+49-69-6301Martin.rosewich@kgu.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 11, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

DE(1)