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
68 participants
OBSERVATIONAL
2011-10-31
2012-10-31
Brief Summary
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Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment) Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant grass pollen allergy without SCIT.
The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the patients to record symptoms during the adjacent pollen season. A blood sample was drawn to analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5, IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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under SIT
patients completed second or third year of SIT. We include the patients directly after last SIT vaccination.
No interventions assigned to this group
after SIT
Patients completed three years of SIT for at least three years. We included them as a follow up.
No interventions assigned to this group
no SIT
These patients were determined randomly. They have a clinically relevant grass pollen allergy. They never had a SIT.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* clinically relevant grass pollen allergy,
* age \> 6 and \< 28
Exclusion Criteria
* regular ingestion of antihistamine,
* systemic steroid therapy,
* lung funtcion VC \< 70%,
* FEV1 \< 65%
7 Years
28 Years
ALL
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Dr. med. Martin Rosewich
Principal Investigator
Principal Investigators
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Stefan Zielen, Prof.
Role: STUDY_DIRECTOR
Johann Wolfgang Goethe University Hospital
Locations
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Johann Wolfgang Goethe-university
Frankfurt/M, Hesse, Germany
Countries
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References
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Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: a randomized controlled trial. J Allergy Clin Immunol. 2010 Nov;126(5):942-9. doi: 10.1016/j.jaci.2010.06.002. Epub 2010 Jul 10.
Martin M, Michalek SM, Katz J. Role of innate immune factors in the adjuvant activity of monophosphoryl lipid A. Infect Immun. 2003 May;71(5):2498-507. doi: 10.1128/IAI.71.5.2498-2507.2003.
Drachenberg KJ, Heinzkill M, Urban E, Woroniecki SR. Efficacy and tolerability of short-term specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A (MPL) for children and adolescents. Allergol Immunopathol (Madr). 2003 Sep-Oct;31(5):270-7. doi: 10.1016/s0301-0546(03)79195-2.
Rosewich M, Schulze J, Eickmeier O, Telles T, Rose MA, Schubert R, Zielen S. Tolerance induction after specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A in children. Clin Exp Immunol. 2010 Jun;160(3):403-10. doi: 10.1111/j.1365-2249.2010.04106.x. Epub 2010 Mar 16.
Rosewich M, Schulze J, Fischer von Weikersthal-Drachenberg KJ, Zielen S. Ultra-short course immunotherapy in children and adolescents during a 3-yrs post-marketing surveillance study. Pediatr Allergy Immunol. 2010 Feb;21(1 Pt 2):e185-9. doi: 10.1111/j.1399-3038.2009.00953.x. Epub 2009 Dec 8.
Other Identifiers
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FRA-2012-SCIT
Identifier Type: -
Identifier Source: org_study_id
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