A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis - Full Text View

Sponsored by:	Cytos Biotechnology AG
Information provided by:	Cytos Biotechnology AG
ClinicalTrials.gov Identifier:	NCT00574223

Purpose

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

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	Phase II

MedlinePlus related topics: Allergy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy

Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:

Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life [ 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 ]

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) subcutaneous injections at 8 visits
Arm 2: Placebo Comparator	Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo subcutaneous injections at 8 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 rhinoconjunctivits 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574223

Locations

Switzerland
Cytos Biotechnology (Sponsor's Headquarter)
Schlieren, Switzerland, CH-8952

Sponsors and Collaborators

Cytos Biotechnology AG

Investigators

Study Director:

Philipp Mueller, MD

Cytos Biotechnology

More Information

Responsible Party:	Cytos Biotechnology AG ( Philipp Mueller, MD, Head of Clinical Development, EVP )
Study ID Numbers:	CYT005-AllQbG10 04, No
Study First Received:	December 14, 2007
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00574223
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009