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Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00652223
First received: April 1, 2008
Last updated: April 4, 2008
Last verified: April 2008
  Purpose

The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.


Condition Intervention Phase
Perennial Allergic Rhinoconjunctivitis
Allergic Asthma
Biological: CYT005-AllQbG10
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Enrollment: 21
Study Start Date: March 2005
Study Completion Date: November 2005
Arms Assigned Interventions
Experimental: 1 Biological: CYT005-AllQbG10
Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites
  • Mild asthma
  • Females only if non-reproductive or agree to practice an effective and accepted method of contraception

Exclusion Criteria:

  • Relevant cardiovascular, renal, pulmonary or endocrine disease
  • History of autoimmune disease
  • Severe allergies
  • History of active infectious disease
  • Current diagnosis or history of malignancy
  • Relevant neurological or psychiatric disorder
  • Pregnancy or lactation
  • History of alcohol abuse or other recreational drugs
  • Use of an investigational drug within three month before enrolment
  • Blood donation within 30 days before enrolment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652223

Locations
Switzerland
University Hospital Zurich, Department of Dermatology
Zurich, Switzerland, 8091
Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
Study Director: Philipp Mueller, MD Cytos Biotechnology AG
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00652223     History of Changes
Other Study ID Numbers: CYT005-AllQbG10 01
Study First Received: April 1, 2008
Last Updated: April 4, 2008
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Asthma
Conjunctivitis
Conjunctivitis, Allergic
Bronchial Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014