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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergopharma GmbH & Co. KG
- Enrollment
- 160
- Locations
- 1
- 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
Arms & Interventions
Placebo
Placebo was given the same way as a sublingual preparation.
Intervention: Comparator (Other)
Liquid formulation of an extract of a 6 grass pollen mixture
Sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.
The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose.
Intervention: Grass pollen formulation (Biological)
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)