Status:
COMPLETED
Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
ImVision GmbH, Hannover
Conditions:
Allergy to Cat Dander
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is placebo controlled, double blind, randomised, two arm dose escalation of a new product for specific immunotherapy in cat allergic patients
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00718679
Start Date
July 1 2008
End Date
February 1 2010
Last Update
February 11 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Clinical Research University Hospital Zurich
Zurich, Switzerland