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Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

NCT ID: NCT00652223

Last Updated: 2008-04-09

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/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-11-30

Brief Summary

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The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.

Detailed Description

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Conditions

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Perennial Allergic Rhinoconjunctivitis Allergic Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

CYT005-AllQbG10

Intervention Type BIOLOGICAL

Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT

Interventions

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CYT005-AllQbG10

Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites
* Mild asthma
* Females only if non-reproductive or agree to practice an effective and accepted method of contraception

Exclusion Criteria

* Relevant cardiovascular, renal, pulmonary or endocrine disease
* History of autoimmune disease
* Severe allergies
* History of active infectious disease
* Current diagnosis or history of malignancy
* Relevant neurological or psychiatric disorder
* Pregnancy or lactation
* History of alcohol abuse or other recreational drugs
* Use of an investigational drug within three month before enrolment
* Blood donation within 30 days before enrolment
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cytos Biotechnology AG

INDUSTRY

Sponsor Role lead

Principal Investigators

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Philipp Mueller, MD

Role: STUDY_DIRECTOR

Cytos Biotechnology AG

Locations

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University Hospital Zurich, Department of Dermatology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CYT005-AllQbG10 01

Identifier Type: -

Identifier Source: org_study_id