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

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: June 4, 2013
Last verified: February 2013

December 14, 2007
June 4, 2013
September 2006
March 2008   (final data collection date for primary outcome measure)
Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2) [ Time Frame: baseline versus 2 months after baseline ] [ Designated as safety issue: No ]

The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted).

The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2.

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 ]
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 Rhinoconjunctivitis
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 rhinoconjunctivitis 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
February 2013

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