A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
Primary Purpose
Allergic Rhinitis, Allergic Conjunctivitis
Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
modified allergen extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis
- 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 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,
- Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
modified allergen extract
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Symptom and medication score
Secondary Outcome Measures
Safety of the treatment
Documentation of adverse events
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Clinical global improvement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01012752
Brief Title
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
Official Title
A Multicenter, Double-Blind, Placebo-Controlled Study With a Modified Allergen Extract for Specific Immunotherapy in Patients With Seasonal Allergic Rhinitis/Rhinoconjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxall Medizin
4. Oversight
5. Study Description
Brief Summary
This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
modified allergen extract
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
modified allergen extract
Intervention Description
subcutaneous injections
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injections
Primary Outcome Measure Information:
Title
Symptom and medication score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety of the treatment
Time Frame
1 year
Title
Documentation of adverse events
Time Frame
1 year
Title
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time Frame
1 year
Title
Clinical global improvement
Time Frame
1 year
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:
Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis
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 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,
Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roxall Medizin
Phone
+49408972520
Facility Information:
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
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