NCT00264459CompletedPhase 3
A Multicentre, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of a Perennial Sublingual Specific Immunotherapy With a Liquid Formulation of an Extract of a Six Grass Pollen-mixture in Patients With Clinically Relevant Grass Pollen Sensitivity.
Allergopharma GmbH & Co. KG2 sites in 1 country160 target enrollmentStarted: February 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergopharma GmbH & Co. KG
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Symptom and Medication Score (SMS)
Study Overview
Brief Summary
The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,
Exclusion Criteria
- •Serious chronic diseases, Other perennial allergies
Outcomes
Primary Outcomes
Symptom and Medication Score (SMS)
Time Frame: 1.5 years of therapy
The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.
Secondary Outcomes
- Visual Rating Scale(1.5 years)
Investigators
Study Sites (2)
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