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:
Cytos Biotechnology AG
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00652223
First received: April 1, 2008
Last updated: April 4, 2008
Last verified: April 2008
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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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
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| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652223
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00652223 History of Changes |
| Other Study ID Numbers: | CYT005-AllQbG10 01 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 4, 2008 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Asthma Conjunctivitis, Allergic Bronchial Diseases Conjunctival Diseases Conjunctivitis Eye Diseases Hypersensitivity |
Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on February 27, 2015