Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2004
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 2, 2007
CompletedFirst Posted
Study publicly available on registry
October 5, 2007
CompletedOctober 5, 2007
September 1, 2007
October 2, 2007
October 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of the shortened specific immunotherapy.
may 2004 - march 2005
Secondary Outcomes (1)
Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups.
may 2004 - march 2005
Study Arms (2)
1
ACTIVE COMPARATORStandard specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany
2
ACTIVE COMPARATORShortened specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany
Interventions
We treat each patient with mite-allergen following the two different protocols.
Eligibility Criteria
You may qualify if:
- informed consent of patient and/or parents
- age \>6 and \<18 years
- bronchial asthma I° or II°
- allergy on house dust-mite
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, 60590, Germany
Related Publications (2)
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.
PMID: 12915987BACKGROUNDTabar 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.
PMID: 15990782BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Zielen, M.D., Ph.D.
Goethe University, Department of Pulmonology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 2, 2007
First Posted
October 5, 2007
Study Start
May 1, 2004
Study Completion
March 1, 2005
Last Updated
October 5, 2007
Record last verified: 2007-09