Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00718679
• Date of registration: 18/07/2008
• Prospective Registration: No
• Primary sponsor: University of Zurich
• Public title: Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial IVN-CAT-001B
• Scientific title: Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial
• Date of first enrolment: July 2008
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00718679
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Switzerland

Contacts

• Name: Gabriela Senti, MD
• Affiliation: UniversitaetsSpital Zuerich

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Allergy to Cat Dander

Intervention(s)

Drug: Placebo

Drug: IVN201

Primary Outcome(s)

Saftety tolerability and efficacy [Time Frame: 2009]

Secondary ID(s)

IVN-CAT-001B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ImVision GmbH, Hannover