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

October 4, 2007 updated by: Johann Wolfgang Goethe University Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

see above

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Goethe University, Department of Pulmonology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of the shortened specific immunotherapy.
Time Frame: may 2004 - march 2005
may 2004 - march 2005

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Collaborators

Allergopharma GmbH & Co. KG

Investigators

  • Principal Investigator: Stefan Zielen, M.D., Ph.D., Goethe University, Department of Pulmonology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 4, 2007

First Posted (Estimate)

October 5, 2007

Study Record Updates

Last Update Posted (Estimate)

October 5, 2007

Last Update Submitted That Met QC Criteria

October 4, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 97/04/FFM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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