Clinical trial NCT00718679: Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial
Official title: Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy to Cat Dander
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ImVision GmbH, Hannover
First posted: 2008-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Saftety tolerability and efficacy
timeFrame: 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Center for Clinical Research University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Gabriela Senti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freiberger SN, Zehnder M, Gafvelin G, Gronlund H, Kundig TM, Johansen P. IgG4 but no IgG1 antibody production after intralymphatic immunotherapy with recombinant MAT-Feld1 in human. Allergy. 2016 Sep;71(9):1366-70. doi: 10.1111/all.12946. Epub 2016 Jun 17.
citation: Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.