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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00540150

Enrollment

Registered

2007-10-05

Start date

2004-05-31

Completion date

2005-03-31

Last updated

2007-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunotherapy

Keywords

Immunotherapy, Mite, Asthma, bronchial provocation, SIT, specific immunotherapy

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.

Detailed description

see above

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety of the shortened specific immunotherapy.	may 2004 - march 2005

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026