Lung Function, LCI, Bronchial Inflammation and Epigenetic... | NCT02627833

Studies
Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO

NCT02627833

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Unknown status

Last Update Posted

Dec 11, 2015Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Bronchiolitis Obliterans

Interventions

observation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Jul 2016Estimated

Completion Date

Not provided

First Submitted Date

Dec 9, 2015

First Submission Date that Met QC Criteria

Dec 9, 2015

First Posted Date

Dec 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2015

Last Update Posted Date

Dec 11, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The purpose of this study is to compare miRNA pattern, lung function values, bronchial inflammation and the Lung clearance index of Patients with Bronchiolitis obliterans aged between 6 up to 30 years of age with a matched control group.

The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.

Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) and by cytometric bead assay (CBA). miRNA samples will be collected, processand compared with the miRNA database at http://www.mirbase.org/

Methods and Work Programme:

Measurement of nitric oxide in expired air (FeNO)
Lung function testing with spirometry and body plethysmography
Lung clearance index (LCI)
Bronchodilation
Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system), miRNA analysis
Induced sputum for inflammatory mediators and microbiological investigations

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subject Group		Patients suffering from Bronchiolitis Obliterans	Other: observation
Control Group		Age and sex matched control group	Other: observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observation	Other	Record lung function, Lung clearance index, inflammatory status	Control Group Subject Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
miRNA Status	Blood sample to determine candidate miRNA for Bronchiolitis obliterans	single day observation

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Lung clearance index (LCI)	Determine Lung clearance index with the Oxygen washout method	single day observation
FVC [%-pred.]	Compare FVC [%-pred.] of BO Patients with a healthy control group

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

<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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martin Rosewich, MD	Contact	+49-69-6301	5381	Martin.rosewich@kgu.de

Overall Officials

Name	Affiliation	Role
Martin Rosewich, MD	Johann Wolfgang Goethe University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital, Goethe-University	Recruiting	Frankfurt am Main	Hesse	60590	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15635614	Background	Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. doi: 10.1002/ppul.20145.
9824023	Background	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.

ID	Term
D001988	Bronchiolitis
D001991	Bronchitis
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

ID	Term
D008722	Methods
D008919	Investigative Techniques