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

This study has been completed.
Sponsor:
Collaborator:
Allergopharma GmbH & Co. KG
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00540150
First received: October 2, 2007
Last updated: October 4, 2007
Last verified: September 2007
  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
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:


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 GmbH & Co. KG
Investigators
Principal Investigator: Stefan Zielen, M.D., Ph.D. Goethe University, Department of Pulmonology
  More Information

Publications:
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 April 22, 2014