Bronchial Inflammation in Patients With Severe Immune Deficiency Under Immunoglobulin Treatment
|ClinicalTrials.gov Identifier: NCT01359384|
Recruitment Status : Unknown
Verified May 2011 by Johann Wolfgang Goethe University Hospital.
Recruitment status was: Not yet recruiting
First Posted : May 24, 2011
Last Update Posted : May 24, 2011
The purpose of the clinical trial is to gain a more substantial understanding of bronchial inflammation in patients with severe primary immundeficiency under immunoglobulin therapy. It is intended to characterize the systemical such as the bronchial inflammation (IL-1, IL-2, IL-6, IL-8, IL-17, TNF-a, NFkB, IFN-gamma, TGF-beta, TLR2 und TLR4)in children with severe immune deficiency in order to generate new treatment strategies based on the results.
The methods being used for characterization purposes within this trial include specific lung function tests ( spirography, bodyplethysmographie w. helium) such as the analysis of eNO and eCO. Furthermore, sputum and serum samples are being 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 the study the investigators will retrospectively and systematically evaluate the available high-resolution computed tomography (HRCT) studies of affected patients.
|Condition or disease|
The clinical trial contains a patient collective of 50 (6-60 years of age) that shall be eventually compared to a control group equal in age and gender. Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
- Measurement of nitric oxide in expired air (eNO)
- Measurement of carbon monoxide in the exhaled air (eCO)
- Lung function testing with spirography and bodyplethysmographie
- 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
*Unspecific bronchial provocation test with methacholine (PD20 FEV1 metacholine)
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Observational Model:||Case Control|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
25 patients suffering from severe immune deficiency under immunoglobulin therapy
25 matched controls not suffering from severe immune deficiency
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359384
|Contact: Martin Rosewich, MD||+(49) 69 6301 ext 5381||Martin.Rosewich@kgu.de|
|Children's Hospital, Goethe-University||Not yet recruiting|
|Frankfurt a. Main, Hessen, Germany, 60590|
|Contact: Martin Rosewich, MD Martin.Rosewich@kgu.de|