Bronchial Inflammation in Patients With Severe Immune Deficiency Under Immunoglobulin Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Johann Wolfgang Goethe University Hospital

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 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
Immune Deficiency

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)


  • 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
Time Perspective: Prospective
Study Start Date : May 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

affected patients
25 patients suffering from severe immune deficiency under immunoglobulin therapy
non-affected patients
25 matched controls not suffering from severe immune deficiency

Biospecimen Retention:   Samples With DNA
whole blood, serum and sputum

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study is carried out in children and young adults (6-60 years of age). Both the patients (25) and the healthy subjects (25) are recruited from the outpatient clinic of the departement of Pediatric Allergy and Pulmonology and the departement of Pediatric Immune deficiency , University Clinic, JW Goethe University, Frankfurt/M, Germany

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01359384

Contact: Martin Rosewich, MD +(49) 69 6301 ext 5381

Children's Hospital, Goethe-University Not yet recruiting
Frankfurt a. Main, Hessen, Germany, 60590
Contact: Martin Rosewich, MD   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital

Responsible Party: Prof. Dr. med. Stefan Zielen, Johann Wolfgang Goethe University Hospitals Identifier: NCT01359384     History of Changes
Other Study ID Numbers: KGU 84-11
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: May 2011

Keywords provided by Johann Wolfgang Goethe University Hospital:
severe primary immune deficieny

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs