Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects With Epicutanoeus Allergen Administration (ZU-SkinSIT-003)
| Tracking Information | |||||
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| First Received Date ICMJE | October 21, 2008 | ||||
| Last Updated Date | January 31, 2011 | ||||
| Start Date ICMJE | October 2008 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Comparison of the efficacy of the placebo patch with the allergen patch with combined symptom medication score [ Time Frame: 2009 - 2011 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Comparison of the efficacy of the placebo patch with the allergen patch with combined symptom medication score [ Time Frame: 2009 - 2010 ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00777374 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects With Epicutanoeus Allergen Administration | ||||
| Official Title ICMJE | Single Center Phase I/IIa, Placebo Controlled, Randomized, Double-blind Preseasonal Study to Assess Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration | ||||
| Brief Summary | Seasonal rhinoconjunctivitis or hay fever is a common atopic condition that is frequently seen in clinical practice. Grass pollen is the major cause of pollinosis in many parts of the world. Immunotherapy is the only treatment that may affect the natural course of allergic diseases, and it may also prevent the development of asthma in patients with allergic rhinitis. With conventional subcutaneous desensitization the duration of treatment is around 3-5 years and usually comprises around 30-100 allergen injections. As high allergen doses have to be injected, allergic side effects may occur and patients must stay under medical supervision for at least 1 hour. Transcutaneous immunization (TCI) is a needle -free technique that delivers antigens and adjuvants to potent epicutaneous immune cells. The aim of the new epicutaneous route of desensitization is to more specifically target the immune system by loading Langerhans cells with the allergen. Lower antigen doses can be applied, such that side effects are reduced. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Allergic Rhinoconjunctivitis | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 97 | ||||
| Completion Date | November 2010 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria: Written informed consent History of grass pollen allergic rhinitis for at least two years Male and female between 18 years to 65 years Positive skin-prick test to grass pollen Positive conjunctival provocation test Exclusion criteria: Eczematous skin lesions on the upper arms Perennial rhinitis due to perennial allergies or anatomical reason (polyps, septal deviation) Symptoms of infectious disease with rhinitis in between the last week Surgical intervention in between the last 30 days Pregnancy or nursing History of HIV or AIDS History of mastocytosis (cutaneous or systemic) History of significant cardiovascular disease Uncontrolled Hypertension (blood pressure > 160 / 95) History of significant pulmonary, renal and/or hepatic disease History of significant hematological disorder Moderate or severe asthma History of malignancy Significant neurological or psychatric disease History of active autoimmune disease Antihistamines with longed half-lives in the last week Systemic or topical steroids for 5 days Depot corticosteroids for the last two months Active infectious disease Adipositas per magna Contraindicated medications:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00777374 | ||||
| Other Study ID Numbers ICMJE | ZU-SkinSIT-003 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | PD Dr. Thomas Kündig, University of Zurich | ||||
| Study Sponsor ICMJE | University of Zurich | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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