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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: October 2, 2007   Last Updated: 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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
1: Active Comparator
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.
2: Active Comparator
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.

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, Hessen
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.

Study ID Numbers: 97/04/FFM
Study First Received: October 2, 2007
Last Updated: October 4, 2007
ClinicalTrials.gov Identifier: NCT00540150     History of Changes
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 08, 2010



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