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

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ClinicalTrials.gov Identifier: NCT00540150
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : October 5, 2007
Sponsor:
Collaborator:
Allergopharma GmbH & Co. KG
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Immunotherapy Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot) Phase 3

Detailed Description:
see above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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.
Study Start Date : May 2004
Actual Study Completion Date : March 2005

Arm Intervention/treatment
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




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

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


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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

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