- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01359384
Bronchial Inflammation in Patients With Severe Immune Deficiency Under Immunoglobulin Treatment
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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)
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Hessen
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Frankfurt a. Main, Hessen, Tyskland, 60590
- Children's Hospital, Goethe-University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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affected patients
25 patients suffering from severe immune deficiency under immunoglobulin therapy
|
non-affected patients
25 matched controls not suffering from severe immune deficiency
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Eickmeier O, Huebner M, Herrmann E, Zissler U, Rosewich M, Baer PC, Buhl R, Schmitt-Grohe 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.
- 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. doi: 10.1016/0091-6749(91)90306-9.
- 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. doi: 10.1016/j.intimp.2004.02.011.
- 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.
- 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. doi: 10.1046/j.1365-2249.1997.4831379.x.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KGU 84-11
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