Clinical Status & Bronchial Inflammation in Patients With Bronchiolitis

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01327248
Study type	Observational
Source	Johann Wolfgang Goethe University Hospitals
Contact
Status	Completed
Phase	N/A
Start date	May 2011
Completion date	June 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03603899` - Hp129 Xenon Imaging and BOS in Lung Transplantation	Phase 1/Phase 2
Recruiting	`NCT04098445` - TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
Completed	`NCT02441413` - Transplant Optimization Using Functional Imaging (TROFI)	N/A
Recruiting	`NCT02543073` - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT	Phase 1/Phase 2
Terminated	`NCT01432080` - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant	Phase 2
Recruiting	`NCT00163696` - Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease	N/A
Completed	`NCT00029328` - Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation	Phase 1/Phase 2
Terminated	`NCT01163786` - A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD	Phase 2
Recruiting	`NCT02627833` - Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO	N/A
Completed	`NCT01212406` - Vitamin D in Bronchiolitis Obliterans Syndrome	Phase 4
Completed	`NCT01211509` - Montelukast in Bronchiolitis Obliterans Syndrome	Phase 4
Completed	`NCT00701922` - Surveillance Study of Viral Infections Following Lung Transplantation	N/A
Completed	`NCT00141726` - Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant	Phase 2
Recruiting	`NCT05922761` - BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)	Phase 2
Recruiting	`NCT05881538` - High Intensity Intervallic Training in Children With Bronchiolitis Obliterans	N/A
Terminated	`NCT04655508` - Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation	Phase 3
Withdrawn	`NCT02109237` - Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3	N/A
Recruiting	`NCT05932316` - Evaluating Bronchodilator Response in Patients With Bronchiectasis	N/A
Active, not recruiting	`NCT03656926` - Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2)	Phase 3
Completed	`NCT01206309` - Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans — Frabo

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms