Bronchial Inflammation in Patients With Severe Immune Deficiency Under Immunoglobulin Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01359384
First received: May 19, 2011
Last updated: May 23, 2011
Last verified: May 2011
  Purpose

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
Immune Deficiency

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Biospecimen Retention:   Samples With DNA

whole blood, serum and sputum


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
affected patients
25 patients suffering from severe immune deficiency under immunoglobulin therapy
non-affected patients
25 matched controls not suffering from severe 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)

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)

  Eligibility

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359384

Contacts
Contact: Martin Rosewich, MD +(49) 69 6301 ext 5381 Martin.Rosewich@kgu.de

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

Publications:
Responsible Party: Prof. Dr. med. Stefan Zielen, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01359384     History of Changes
Other Study ID Numbers: KGU 84-11
Study First Received: May 19, 2011
Last Updated: May 23, 2011
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014