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Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy
This study has been completed.

First Received on October 2, 2007.   Last Updated on October 4, 2007   History of Changes
Sponsor: Johann Wolfgang Goethe University Hospitals
Collaborator: Allergopharma Joachim Ganzer KG
Information provided by: Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00540150
  Purpose

We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy.

Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.


Condition Intervention Phase
Immunotherapy
 Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy in a Randomized Study Depending on Mite-Depot Supplement in Children and Adolescents With Allergic Bronchial Asthma.

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures:
  • Safety of the shortened specific immunotherapy. [ Time Frame: may 2004 - march 2005 ]

Secondary Outcome Measures:
  • Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups. [ Time Frame: may 2004 - march 2005 ]

Enrollment: 34
Study Start Date: May 2004
Study Completion Date: March 2005
Arms Assigned Interventions
Active Comparator: 1
Standard specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany
 Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)
We treat each patient with mite-allergen following the two different protocols.
Other Name: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany
Active Comparator: 2
Shortened specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany
 Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)
We treat each patient with mite-allergen following the two different protocols.
Other Name: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany

Detailed Description:

see above

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent of patient and/or parents
  • age >6 and <18 years
  • bronchial asthma I° or II°
  • allergy on house dust-mite

Exclusion Criteria:

  • age <6 and >18 years
  • vital capacity <80% or FEV1 <70%
  • pregnancy
  • inhalative or systemic steroid use
  • bronchial asthma III° or IV°
  • heavy exacerbation during the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540150

Locations
Germany
Goethe University, Department of Pulmonology
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Allergopharma Joachim Ganzer KG
Investigators
Principal Investigator: Stefan Zielen, M.D., Ph.D. Goethe University, Department of Pulmonology
  More Information

Publications:
Hansen I, Hormann K, Stuck BA, Schneider-Gene S, Mosges R, Klimek L. [Cluster-immunotherapy in seasonal allergic rhinitis: safety aspects of induction therapy with depot allergoids (Purethal)] Laryngorhinootologie. 2003 Aug;82(8):558-63. German.
Tabar AI, Echechipia S, Garcia BE, Olaguibel JM, Lizaso MT, Gomez B, Aldunate MT, Martin S, Marcotegui F. Double-blind comparative study of cluster and conventional immunotherapy schedules with Dermatophagoides pteronyssinus. J Allergy Clin Immunol. 2005 Jul;116(1):109-18.

ClinicalTrials.gov Identifier: NCT00540150     History of Changes
Other Study ID Numbers: 97/04/FFM
Study First Received: October 2, 2007
Last Updated: October 4, 2007
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Immunotherapy
Mite
Asthma
 bronchial provocation
SIT
specific immunotherapy

ClinicalTrials.gov processed this record on February 09, 2012



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