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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-02-28

Brief Summary

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This study is placebo controlled, double blind, randomised, two arm dose escalation of a new product for specific immunotherapy in cat allergic patients

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Detailed Description

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Conditions

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Allergy to Cat Dander

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Study drug

Group Type EXPERIMENTAL

IVN201

Intervention Type DRUG

Intralymphativ injection of the study drug

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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IVN201

Intralymphativ injection of the study drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No