Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy
NCT ID: NCT00540150
Last Updated: 2007-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
34 participants
INTERVENTIONAL
2004-05-31
2005-03-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Standard specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany
specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)
We treat each patient with mite-allergen following the two different protocols.
2
Shortened specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany
specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)
We treat each patient with mite-allergen following the two different protocols.
Interventions
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specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)
We treat each patient with mite-allergen following the two different protocols.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age \>6 and \<18 years
* bronchial asthma I° or II°
* allergy on house dust-mite
Exclusion Criteria
* vital capacity \<80% or FEV1 \<70%
* pregnancy
* inhalative or systemic steroid use
* bronchial asthma III° or IV°
* heavy exacerbation during the last 3 months
6 Years
18 Years
ALL
No
Sponsors
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Allergopharma GmbH & Co. KG
INDUSTRY
Johann Wolfgang Goethe University Hospital
OTHER
Principal Investigators
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Stefan Zielen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Goethe University, Department of Pulmonology
Locations
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Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, Germany
Countries
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References
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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.
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.
Other Identifiers
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97/04/FFM
Identifier Type: -
Identifier Source: org_study_id