LCI and Bronchial Inflammation in Patients With BO

NCT02495597 | Completed

• 1 other identifier: EC 124/13
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators here compare lung function parameters (RV, RV/TLC and FEF75) with the results of the Lung Clearance index (LCI) . Further this study evaluates bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 28 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with DLCO) and compare the results with the LCI. Further we will measure the fraction of exhaled nitric oxide (FeNO) and draw a blood sample to determine the level of systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This study will set baseline markers for future interventional studies.

Conditions

Bronchiolitis Obliterans

Keywords

bronchial inflammation; Bronchiolitis obliterans; Sputum; Blood; Inflammation; adaptive immune system; innate immune system

Outcome Measures

Primary Outcomes (1)

• LCI compared to RV/TLC%-pred.

  Correlation of these lung function Parameters in patients with BO compared to healthy controls

  during Visit 1 (single day, single observation)

Secondary Outcomes (14)

• change of sputum cell count over time (percentage of neutrophils)

  during Visit 1 (single day, single observation)

• Comparison of low CrP

  during Visit 1 (single day, single observation)

• FVC (%-pred.)

  during Visit 1 (single day, single observation)

• FEV1 (%-pred.)

  during Visit 1 (single day, single observation)

• Tiffeneau-Index

  during Visit 1 (single day, single observation)

Study Arms (2)

Subject-Group

Patients suffering from doctors diagnosed bronchiolitis obliterans

Other: no intervention - just observational

Control Group

age- and sex matched to subject-group

Other: no intervention - just observational

Interventions

no intervention - just observational OTHER

Control Group; Subject-Group

Eligibility Criteria

• Age: 6 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from Bronchiolitis obliterans and controls

You may qualify if:

• informed consent
• between 6 and 28 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:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Children's Hospital, Goethe-University

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Links

• Kurland G, Michelson P. Bronchiolitis obliterans in children. Pediatr Pulmonol. 2005 Mar;39(3):193-208. Review
• Smith KJ, Fan LL. Insights into post-infectious bronchiolitis obliterans in children. Thorax. 2006 Jun;61(6):462-3.
• 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.
• Pichler MN, Reichenbach J, Schmidt H, Herrmann G, Zielen S. Severe adenovirus bronchiolitis in children. Acta Paediatr. 2000 Nov;89(11):1387-9.

Biospecimen

Retention: SAMPLES WITH DNA

blood, sputum cells, sputum supernatans

MeSH Terms

Conditions

Bronchiolitis Obliterans; Inflammation

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Rosewich, MD

  Johann Wolfgang Goethe University Hospital

  PRINCIPAL INVESTIGATOR

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: July 6, 2015
• First Posted: July 13, 2015
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

DE (1)