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Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540150
First Posted: October 5, 2007
Last Update Posted: October 5, 2007
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.
Collaborator:
Allergopharma GmbH & Co. KG
Information provided by:
Johann Wolfgang Goethe University Hospital
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00540150


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