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CompletedNCT00540150Updated Oct 5, 2007

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

A Phase 3 interventional study of specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot) in Immunotherapy, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2007-10-05.

Sponsored by Johann Wolfgang Goethe University Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

Read the detailed description

see above

02

Conditions studied

  • Immunotherapy

Keywords

  • Immunotherapy
  • Mite
  • Asthma
  • bronchial provocation
  • SIT
  • specific immunotherapy
03

In context

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    1

    Standard specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany

    Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)

  • Active comparator
    2

    Shortened specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany

    Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)

Interventions

  • Biologicalspecific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)

    We treat each patient with mite-allergen following the two different protocols.

    Also known as: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany

06

What researchers measure

Primary outcomes

  1. Safety of the shortened specific immunotherapy.

    Time frame: may 2004 - march 2005

Secondary outcomes

  1. Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups.

    Time frame: may 2004 - march 2005

07

Study locations

1 site
  • Goethe University, Department of Pulmonology
    Frankfurt, Hessen 60590, Germany
08

References and documents

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. doi: 10.1055/s-2003-41234. German. PubMed 12915987 ↗
  • 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. doi: 10.1016/j.jaci.2005.05.005. PubMed 15990782 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00540150
Lead sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
Allergopharma GmbH & Co. KG
First posted
Oct 5, 2007
Start date
May 2004
Completion
Mar 2005
Last update
Oct 5, 2007

Study contacts

Stefan Zielen, M.D., Ph.D.
principal investigator · Goethe University, Department of Pulmonology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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