Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen
Phase 3
Completed
- Conditions
- Allergic Rhinitis
- Registration Number
- NCT01012531
- Lead Sponsor
- Roxall Medizin
- Brief Summary
The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Symptom and medication score 1 year
- Secondary Outcome Measures
Name Time Method Safety of the treatment during the study period 1 year Documentation of adverse events 1 year Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season 1 year Global evaluation and Quality of life questionnaire 1 year
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of cluster-allergoid CLUSTOID Grass Pollen in subcutaneous immunotherapy for allergic rhinoconjunctivitis?
How does subcutaneous cluster immunotherapy with CLUSTOID Grass Pollen compare to standard allergen immunotherapy in treating grass pollen-induced allergic rhinitis?
What biomarkers correlate with response to CLUSTOID Grass Pollen subcutaneous immunotherapy in patients with allergic rhinoconjunctivitis and grass/rye sensitization?
What are the long-term safety outcomes of glutaraldehyde-polymerized allergen extracts in phase 3 trials for allergic rhinitis?
Are there combination therapies or competitor drugs targeting grass pollen allergy that show improved efficacy over CLUSTOID Grass Pollen immunotherapy?
Trial Locations
- Locations (1)
Zentrum für Rhinologie und Allergologie
🇩🇪Wiesbaden, Germany
Zentrum für Rhinologie und Allergologie🇩🇪Wiesbaden, Germany