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

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. Identifier: NCT00652223
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : April 9, 2008
Information provided by:
Cytos Biotechnology AG

Brief Summary:
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 or disease Intervention/treatment Phase
Perennial Allergic Rhinoconjunctivitis Allergic Asthma Biological: CYT005-AllQbG10 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
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
Study Start Date : March 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Pinkeye
Drug Information available for: Odactra

Arm Intervention/treatment
Experimental: 1 Biological: CYT005-AllQbG10
Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT

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

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

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 identifier (NCT number): NCT00652223

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University Hospital Zurich, Department of Dermatology
Zurich, Switzerland, 8091
Sponsors and Collaborators
Cytos Biotechnology AG
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Study Director: Philipp Mueller, MD Cytos Biotechnology AG
Layout table for additonal information Identifier: NCT00652223    
Other Study ID Numbers: CYT005-AllQbG10 01
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: April 9, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases