Back to resultsA Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Primary Purpose
Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
House dust mite allergen extract in combination with CYT003-QbG10-placebo
CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinoconjunctivitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Safety and Tolerability of the Study Treatment by Collection of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00574704
Brief Title
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytos Biotechnology AG
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
Intervention Description
subcutaneous injections at 6 visits
Intervention Type
Drug
Intervention Name(s)
House dust mite allergen extract in combination with CYT003-QbG10-placebo
Intervention Description
subcutaneous injections at 6 visits
Intervention Type
Drug
Intervention Name(s)
CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
Intervention Description
subcutaneous injections at 6 visits
Intervention Type
Drug
Intervention Name(s)
CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
Intervention Description
subcutaneous injections at 6 visits
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
baseline versus 2 months after baseline
Secondary Outcome Measure Information:
Title
Safety and Tolerability of the Study Treatment by Collection of Adverse Events
Time Frame
about 30 min. at each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Mueller, MD
Organizational Affiliation
Cytos Biotechnology
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
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