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.
調査の概要
状態
条件
詳細な説明
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)
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Martin Rosewich, MD
- 電話番号:5381 +(49) 69 6301
- メール:Martin.Rosewich@kgu.de
研究場所
-
-
Hessen
-
Frankfurt a. Main、Hessen、ドイツ、60590
- Children's Hospital, Goethe-University
-
コンタクト:
- Martin Rosewich, MD
- メール:Martin.Rosewich@kgu.de
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
---|
affected patients
25 patients suffering from severe immune deficiency under immunoglobulin therapy
|
non-affected patients
25 matched controls not suffering from severe immune deficiency
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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