Perennial Allergy to House Dust Mite and/or Cat Clinical Trial
Official title:
Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis
| Verified date | April 2009 |
| Source | Cytos Biotechnology AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Estonia: The State Agency of Medicine |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | March 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Estonia | Tartu University Clinic, Lungs Clinic | Tartu | |
| Estonia | Tartu University Clinic, Out-Patients Department | Tartu | |
| Latvia | SNC Uniclinica | Riga | |
| Latvia | The centre of the investigation in treatment of allergic disease | Riga | |
| Lithuania | Kaunas County Hospital, Department of Pulmonology and Allergology | Kaunas | |
| Lithuania | Kaunas Medical University Hospital, Department of Pulmonology and Immunology | Kaunas | |
| Lithuania | Vilnius University Hospital, Centre of Pulmonology and Allergology | Vilnius |
| Lead Sponsor | Collaborator |
|---|---|
| Cytos Biotechnology AG |
Estonia, Latvia, Lithuania,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life | on 4 occations over 1 year | No | |
| Secondary | Safety and tolerability of the vaccine by collection of adverse events | at each visit | No |