- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00575003
Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
April 24, 2009 updated by: Cytos Biotechnology AG
Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis
The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tartu, Estonia, 50406
- Tartu University Clinic, Out-Patients Department
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Tartu, Estonia, 51014
- Tartu University Clinic, Lungs Clinic
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Riga, Latvia, 1003
- The centre of the investigation in treatment of allergic disease
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Riga, Latvia, 1010
- SNC Uniclinica
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Kaunas, Lithuania, 45130
- Kaunas County Hospital, Department of Pulmonology and Allergology
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Kaunas, Lithuania, 50009
- Kaunas Medical University Hospital, Department of Pulmonology and Immunology
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Vilnius, Lithuania, 08661
- Vilnius University Hospital, Centre of Pulmonology and Allergology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens
Exclusion Criteria:
- Clinical 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.
- Any clinically relevant concomitant disease as judged by the investigator.
- Pregnancy or female planning to become pregnant during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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6 subcutaneous injections
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Placebo Comparator: 2
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6 subcutaneous injections
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
Time Frame: on 4 occations over 1 year
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on 4 occations over 1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Safety and tolerability of the vaccine by collection of adverse events
Time Frame: at each visit
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at each visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Audra Blaziene, Vilnius University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Estimate)
April 27, 2009
Last Update Submitted That Met QC Criteria
April 24, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYT003-QbG10 08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Perennial Allergy to House Dust Mite and/or Cat
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ALK-Abelló A/SCompletedHouse Dust Mite AllergyFrance
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Allergopharma GmbH & Co. KGCompletedHouse Dust Mite AllergyGermany
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Universitas AirlanggaNot yet recruiting
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Cytos Biotechnology AGCompletedHouse Dust Mite Allergy | Perennial Allergic Rhinoconjunctivitis
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ASIT Biotech S.A.CompletedHouse Dust Mite AllergyGermany
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Circassia LimitedAdiga Life Sciences, Inc.; Inflamax Research IncorporatedCompletedRhinoconjunctivitis | House Dust Mite Allergy
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Cytos Biotechnology AGCompletedHouse Dust Mite Allergy | Perennial Allergic RhinoconjunctivitisSwitzerland
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T-Balance Therapeutics GmbHCompletedAllergic Asthma | Allergy to House Dust MiteGermany
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Inmunotek S.L.BioClever 2005 S.L.; NTS hub S.LTerminatedEfficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/RhinoconjunctivitisPerennial Allergic Rhinitis | Allergic Rhinoconjunctivitis | House Dust Mite Allergy | Pollen AllergySpain
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Inmunotek S.L.LAT Research; Xolomon Tree S.L.Not yet recruitingAllergic Rhinitis | Allergic Asthma | Allergic Rhinoconjunctivitis | Allergy to House Dust MiteArgentina
Clinical Trials on CYT003-QbG10
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Cytos Biotechnology AGCompleted
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Cytos Biotechnology AGCompletedRhinoconjunctivitis | AllergiesEstonia, Germany, Greece, Latvia, Lithuania, Romania
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Cytos Biotechnology AGCompletedHouse Dust Mite Allergy | Perennial Allergic RhinoconjunctivitisSwitzerland
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Cytos Biotechnology AGCompletedHouse Dust Mite Allergy | Perennial Allergic Rhinoconjunctivitis
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Umar FarooqMerck Sharp & Dohme LLC; University of Iowa; Checkmate PharmaceuticalsSuspended
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Cytos Biotechnology AGWithdrawn
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Cytos Biotechnology AGTerminatedModerate to Severe Allergic AsthmaUnited States, Czech Republic, Germany, Hungary, Israel, Poland, Russian Federation, Ukraine