Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01359384
Status:
UNKNOWN
Last Update Posted:
2011-05-24
First Post:
2011-05-19
Brief Title:
Bronchial Inflammation in Patients With Severe Immune Deficiency Under Immunoglobulin Treatment
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2011-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 TLR4in 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 PCRqRT-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
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 PCRqRT-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
Detailed Description:
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
V1
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
V2
Unspecific bronchial provocation test with methacholine PD20 FEV1 metacholine
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 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
V2
Unspecific bronchial provocation test with methacholine PD20 FEV1 metacholine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None