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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00574223
First Posted: December 17, 2007
Last Update Posted: April 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cytos Biotechnology AG
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • Safety and tolerability of the study treatment by collection of adverse events [ Time Frame: about 30 min. at each visit ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: 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
First Submitted: December 14, 2007
First Posted: December 17, 2007
Last Update Posted: April 27, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Hypersensitivity
Conjunctivitis
Conjunctivitis, Allergic
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate