A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivits
This study has been completed.
Sponsor:
Cytos Biotechnology AG
Information provided by (Responsible Party):
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00574704
First received: December 14, 2007
Last updated: August 20, 2012
Last verified: August 2012
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Purpose
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivits due to house dust mite allergy in a double-blind, placebo-controlled setting
| Condition | Intervention | Phase |
|---|---|---|
|
Perennial Allergic Rhinoconjunctivitis House Dust Mite Allergy |
Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double Blind Placebo Controlled Study to Assess Efficacy and Safety of a Combined Allergen Vaccine (CYT005-AllQbG10) and Its Single Components in Patients With House Dust Mite Allergy |
Resource links provided by NLM:
Further study details as provided by Cytos Biotechnology AG:
Primary Outcome Measures:
- Conjunctival provocation test and skin prick test with house dust mite allergen solutions [ Time Frame: about 1.5 hours on 4 occasions over 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability of the study treatment by collection of adverse events [ Time Frame: about 30 min. at each visit ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | September 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
subcutaneous injections at 6 visits
|
| Placebo Comparator: 2 |
Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
subcutaneous injections at 6 visits
|
| Experimental: 3 |
Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
subcutaneous injections at 6 visits
|
| Placebo Comparator: 4 |
Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
subcutaneous injections at 6 visits
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens
Exclusion Criteria:
- Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
- Use of any concomitant medication that could affect the patient's study treatment response or assessment results
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cytos Biotechnology AG |
| ClinicalTrials.gov Identifier: | NCT00574704 History of Changes |
| Other Study ID Numbers: | CYT005-AllQbG10 03 |
| Study First Received: | December 14, 2007 |
| Last Updated: | August 20, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Hypersensitivity Conjunctivitis, Allergic Conjunctivitis Immune System Diseases |
Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on May 19, 2013