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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00574704
First received: December 14, 2007
Last updated: August 20, 2012
Last verified: August 2012
History of Changes

December 14, 2007
August 20, 2012
September 2006
March 2008   (final data collection date for primary outcome measure)
Conjunctival provocation test and skin prick test with house dust mite allergen solutions [ Time Frame: about 1.5 hours on 4 occasions over 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574704 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivits
Double Blind Placebo Controlled Study to Assess Efficacy and Safety of a Combined Allergen Vaccine (CYT005-AllQbG10) and Its Single Components in Patients With House Dust Mite Allergy

The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivits due to house dust mite allergy in a double-blind, placebo-controlled setting
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Perennial Allergic Rhinoconjunctivitis
  • House Dust Mite Allergy
  • Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
    subcutaneous injections at 6 visits
  • Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
    subcutaneous injections at 6 visits
  • Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
    subcutaneous injections at 6 visits
  • Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
    subcutaneous injections at 6 visits
  • Experimental: 1
    Intervention: Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
  • Placebo Comparator: 2
    Intervention: Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
  • Experimental: 3
    Intervention: Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
  • Placebo Comparator: 4
    Intervention: Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00574704
CYT005-AllQbG10 03
Not Provided
Cytos Biotechnology AG
Cytos Biotechnology AG
Not Provided
Study Director: Philipp Mueller, MD Cytos Biotechnology
Cytos Biotechnology AG
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP