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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

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
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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

No publications provided

Responsible Party:	Philipp Mueller, MD, Head of Clinical Development, EVP, Cytos Biotechnology AG
ClinicalTrials.gov Identifier:	NCT00574223 History of Changes
Other Study ID Numbers:	CYT005-AllQbG10 04
Study First Received:	December 14, 2007
Last Updated:	April 24, 2009
Health Authority:	Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:

Hypersensitivity
Conjunctivitis, Allergic
Conjunctivitis
Immune System Diseases

Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on February 09, 2012