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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00652223

First Posted: April 3, 2008

Last Update Posted: April 9, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Cytos Biotechnology AG

Purpose

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.

Condition	Intervention	Phase
Perennial Allergic Rhinoconjunctivitis Allergic Asthma	Biological: CYT005-AllQbG10	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

Resource links provided by NLM:

Genetics Home Reference related topics: allergic asthma

MedlinePlus related topics: Pinkeye

U.S. FDA Resources

Further study details as provided by Cytos Biotechnology AG:


Enrollment:	21
Study Start Date:	March 2005
Study Completion Date:	November 2005

Arms	Assigned Interventions
Experimental: 1	Biological: CYT005-AllQbG10 Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652223

Locations


Switzerland
University Hospital Zurich, Department of Dermatology
Zurich, Switzerland, 8091

Sponsors and Collaborators

Cytos Biotechnology AG

Investigators


Study Director:	Philipp Mueller, MD	Cytos Biotechnology AG

More Information


ClinicalTrials.gov Identifier:	NCT00652223 History of Changes
Other Study ID Numbers:	CYT005-AllQbG10 01
First Submitted:	April 1, 2008
First Posted:	April 3, 2008
Last Update Posted:	April 9, 2008
Last Verified:	April 2008

Additional relevant MeSH terms:


Asthma Conjunctivitis Conjunctivitis, Allergic Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases	Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Conjunctival Diseases Eye Diseases

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