Allergy to Cat Dander Clinical Trial
— IVN-CAT-001BOfficial title:
Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial
| Verified date | February 2010 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
This study is placebo controlled, double blind, randomised, two arm dose escalation of a new product for specific immunotherapy in cat allergic patients
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | February 2010 |
| Est. primary completion date | February 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion criteria: - History and subjective symptoms of cat dander allergy including cat specific allergic rhinitis - Age 18 to 65 years - Positive reaction to at least one concentration of cat dander allergen in skin prick test, intradermal provocation test and nasal provocation test Exclusion criteria: - Chronic infectious disease - Acute infections - Episode of non-allergic rhinitis within the last 4 weeks - Use of allergen known to predict anaphylactic reactions - Treatment with any other investigational drug within 3 months before trial entry - Vaccination within the last week - Nasal surgery within the last 8 weeks - Progressive fatal disease - Drug or alcohol abuse within the last 5 years - Cat ownership - A history of significant cardiac insufficiency (NYHA stage III-IV) - Coexisting severe disease, e.g. cardiovascular diseases - Acute or history of obstructive respiratory insufficiency ( FEV1 <70%) - Hepatic insufficiency - Relevant anaemia (as judged by investigator) - Blood donation within the last 30 days or intended blood donation (during the study or 30 days after participation) - Pregnancy or breast feeding - Sexually active woman of childbearing potential not actively practicing birth control by using a medically accepted device or therapy - Lack of compliance or other sililar reason, that the investigator believes, precludes satisfactory participation in the study - Systemic glucocorticoid therapy - Allergic asthma and chronic medication with steroids at doses exceeding 200ug/day Treatment with ATII antagonists, B-blocker, ACE inhibitors |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Center for Clinical Research University Hospital Zurich | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich | ImVision GmbH, Hannover |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Saftety tolerability and efficacy | 2009 | Yes |