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

NCT ID: NCT00574704

Last Updated: 2013-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

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The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting

Detailed Description

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Conditions

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Perennial Allergic Rhinoconjunctivitis House Dust Mite Allergy

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

CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)

Intervention Type DRUG

subcutaneous injections at 6 visits

2

Group Type PLACEBO_COMPARATOR

House dust mite allergen extract in combination with CYT003-QbG10-placebo

Intervention Type DRUG

subcutaneous injections at 6 visits

3

Group Type EXPERIMENTAL

CYT003-AllQbG10 in combination with house dust mite allergen extract placebo

Intervention Type DRUG

subcutaneous injections at 6 visits

4

Group Type PLACEBO_COMPARATOR

CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo

Intervention Type DRUG

subcutaneous injections at 6 visits

Interventions

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CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)

subcutaneous injections at 6 visits

Intervention Type DRUG

House dust mite allergen extract in combination with CYT003-QbG10-placebo

subcutaneous injections at 6 visits

Intervention Type DRUG

CYT003-AllQbG10 in combination with house dust mite allergen extract placebo

subcutaneous injections at 6 visits

Intervention Type DRUG

CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo

subcutaneous injections at 6 visits

Intervention Type DRUG

Eligibility Criteria

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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
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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Responsibility Role SPONSOR

Principal Investigators

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Philipp Mueller, MD

Role: STUDY_DIRECTOR

Cytos Biotechnology

Other Identifiers

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CYT005-AllQbG10 03

Identifier Type: -

Identifier Source: org_study_id

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