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

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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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
U.S. FDA Resources

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


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00652223     History of Changes
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:
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