Bronchial Inflammation in Patients With Severe Immune Deficiency Under Immunoglobulin Treatment

Immune Deficiency Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01359384
• Other study ID #: KGU 84-11
• Status: Not yet recruiting
• Phase: N/A
• First received: May 19, 2011
• Last updated: May 23, 2011
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2011
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Martin Rosewich, MD
• Phone: +(49) 69 6301
• Email: Martin.Rosewich[@]kgu.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 60 Years

Eligibility

Inclusion Criteria:

• informed consent

• 6 to 60 years of age

• known severe immune deficiency under immunoglobulin therapy/ no immune deficiency ( depending on study group)

• ability to perform lung function tests and inhalation

Exclusion Criteria:

• < 6 and > 60 years of age on the day of written informed consent

• acute illness with systemic or bronchial inflammation

• every chronic condition or infection (e.g. HIV, tuberculosis, malignancy)

• pregnancy

• known alcohol and/ or drug abuse

• Inability to understand the extent and scope of the study

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Immune Deficiency
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
Germany	Children's Hospital, Goethe-University	Frankfurt a. Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Buehring I, Friedrich B, Schaaf J, Schmidt H, Ahrens P, Zielen S. Chronic sinusitis refractory to standard management in patients with humoral immunodeficiencies. Clin Exp Immunol. 1997 Sep;109(3):468-72. — View Citation

de Gracia J, Vendrell M, Alvarez A, Pallisa E, Rodrigo MJ, de la Rosa D, Mata F, Andreu J, Morell F. Immunoglobulin therapy to control lung damage in patients with common variable immunodeficiency. Int Immunopharmacol. 2004 Jun;4(6):745-53. — View Citation

Eickmeier O, Huebner M, Herrmann E, Zissler U, Rosewich M, Baer PC, Buhl R, Schmitt-Grohé S, Zielen S, Schubert R. Sputum biomarker profiles in cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) and association between pulmonary function. Cytokine. 2010 May;50(2):152-7. doi: 10.1016/j.cyto.2010.02.004. Epub 2010 Feb 23. — View Citation

Sweinberg SK, Wodell RA, Grodofsky MP, Greene JM, Conley ME. Retrospective analysis of the incidence of pulmonary disease in hypogammaglobulinemia. J Allergy Clin Immunol. 1991 Jul;88(1):96-104. — View Citation

Touw CM, van de Ven AA, de Jong PA, Terheggen-Lagro S, Beek E, Sanders EA, van Montfrans JM. Detection of pulmonary complications in common variable immunodeficiency. Pediatr Allergy Immunol. 2010 Aug;21(5):793-805. doi: 10.1111/j.1399-3038.2009.00963.x. Epub 2009 Nov 13. Review. — View Citation