Back to resultsEfficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Subcutaneous injections with highly polymerized allergen extract
Subcutaneous injection with placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
- Positive screening skin prick test (wheal diameter > 3 mm)
- Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
- Signed and dated patient´s Informed Consent,
Exclusion Criteria:
- Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years,
- Simultaneous participation in other clinical trials,
- Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
- Auto-immune disorders,
- Severe chronic inflammatory diseases,
- Malignancy,
- Alcohol abuse,
- Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
- Patients being in any relationship or dependency with the sponsor and/or investigator,
- Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Sites / Locations
- Zentrum für Rhinologie und Allergologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
highly polymerized allergen extract
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Symptom and medication score
Secondary Outcome Measures
Safety of the treatment during the study period
Documentation of adverse events
Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season
Global evaluation and Quality of life questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01012531
Brief Title
Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen
Official Title
Efficacy and Safety of Subcutaneous Cluster Immunotherapy With Cluster-allergoid CLUSTOID Grasses/Rye (Glutaraldehyde-polymerized Allergen Extract of Mixtures of Grass and Rye Allergens) in Patients With Allergic Rhinoconjunctivitis Sensitized to Grass and With or Without Rye Pollen Sensitization
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxall Medizin
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
highly polymerized allergen extract
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Subcutaneous injections with highly polymerized allergen extract
Intervention Description
cluster schedule
Intervention Type
Biological
Intervention Name(s)
Subcutaneous injection with placebo
Intervention Description
cluster schedule
Primary Outcome Measure Information:
Title
Symptom and medication score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety of the treatment during the study period
Time Frame
1 year
Title
Documentation of adverse events
Time Frame
1 year
Title
Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season
Time Frame
1 year
Title
Global evaluation and Quality of life questionnaire
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
Positive screening skin prick test (wheal diameter > 3 mm)
Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
Signed and dated patient´s Informed Consent,
Exclusion Criteria:
Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years,
Simultaneous participation in other clinical trials,
Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
Auto-immune disorders,
Severe chronic inflammatory diseases,
Malignancy,
Alcohol abuse,
Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
Patients being in any relationship or dependency with the sponsor and/or investigator,
Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Facility Information:
Facility Name
Zentrum für Rhinologie und Allergologie
City
Wiesbaden
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen
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