Efficacy and Safety of Sublingual Immunotherapy (SLIT)
A Multicenter Randomized DBPC Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy (SLIT) With Allergen Extracts From Pollen in Patients With Seasonal Allergic Rhinitis
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of specific sublingual immunotherapy (SLIT) with allergen extracts in patients suffering from seasonal allergic rhinitis .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedNovember 3, 2015
November 1, 2015
1 year
November 11, 2009
November 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Symptom and medication score
1 year
Secondary Outcomes (4)
Safety of the treatment
1 year
Documentation of adverse events
1 year
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
1 year
Clinical global improvement
1 year
Study Arms (2)
sublingual application of allergen extract
EXPERIMENTALsublingual application of placebo
PLACEBO COMPARATORInterventions
sublingual application
sublingual application
Eligibility Criteria
You may qualify if:
- Positive history of allergen specific seasonal allergic rhinitis
- 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,
You may not qualify if:
- Previous immunotherapy within the last 3 years,
- Simultaneous participation in other clinical trials,
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roxall Medizinlead
Study Sites (1)
Roxall Medizin
Hamburg, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2009
First Posted
November 13, 2009
Study Start
November 1, 2016
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
November 3, 2015
Record last verified: 2015-11