Back to resultsEffect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
Primary Purpose
Perennial Allergic Rhinoconjunctivitis, Allergic Asthma
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
CYT005-AllQbG10
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinoconjunctivitis
Eligibility 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
Sites / Locations
- University Hospital Zurich, Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00652223
Brief Title
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cytos Biotechnology AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinoconjunctivitis, Allergic Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CYT005-AllQbG10
Intervention Description
Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Mueller, MD
Organizational Affiliation
Cytos Biotechnology AG
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Zurich, Department of Dermatology
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
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