NCT01012882UnknownPhase 3
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
Roxall Medizin1 site in 1 country120 target enrollmentStarted: November 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Symptom and medication score
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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,
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.
Outcomes
Primary Outcomes
Symptom and medication score
Time Frame: 1 year
Secondary Outcomes
- Clinical global improvement(1 year)
- Safety of the treatment(1 year)
- Documentation of adverse events(1 year)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(1 year)
Investigators
Study Sites (1)
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