Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

NCT ID: NCT00575003

Last Updated: 2009-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Perennial Allergy to House Dust Mite and/or Cat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

CYT003-QbG10

Intervention Type DRUG

6 subcutaneous injections

2

Group Type PLACEBO_COMPARATOR

CYT003-QbG10

Intervention Type DRUG

6 subcutaneous injections

Interventions

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CYT003-QbG10

6 subcutaneous injections

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cytos Biotechnology AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Cytos Biotechnology AG

Principal Investigators

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Audra Blaziene

Role: PRINCIPAL_INVESTIGATOR

Vilnius University Hospital

Locations

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Tartu University Clinic, Out-Patients Department

Tartu, , Estonia

Site Status

Tartu University Clinic, Lungs Clinic

Tartu, , Estonia

Site Status

The centre of the investigation in treatment of allergic disease

Riga, , Latvia

Site Status

SNC Uniclinica

Riga, , Latvia

Site Status

Kaunas County Hospital, Department of Pulmonology and Allergology

Kaunas, , Lithuania

Site Status

Kaunas Medical University Hospital, Department of Pulmonology and Immunology

Kaunas, , Lithuania

Site Status

Vilnius University Hospital, Centre of Pulmonology and Allergology

Vilnius, , Lithuania

Site Status

Countries

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Estonia Latvia Lithuania

Other Identifiers

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CYT003-QbG10 08

Identifier Type: -

Identifier Source: org_study_id

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