- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264459
Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Reinbek, Germany, 21465
- Allergopharma GmbH & Co. KG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo was given the same way as a sublingual preparation.
|
Solution for sublingual application containing Placebo.
The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
Other Names:
|
Experimental: 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. |
Solution for 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1.5 years of therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Rating Scale
Time Frame: 1.5 years
|
Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)
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1.5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ludger Klimek, M.D.
Publications and helpful links
General Publications
- Worm M. Efficacy and tolerability of high dose sublingual immunotherapy in patients with rhinoconjunctivitis. Eur Ann Allergy Clin Immunol. 2006 Dec;38(10):355-60.
- Pfaar O, Klimek L. Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: a double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2008 Mar;100(3):256-63. doi: 10.1016/s1081-1206(10)60451-6.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Al0102st
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Grass Pollen Allergy
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Laboratorios Leti, S.L.Completed
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Laboratorios Leti, S.L.Completed
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Aston UniversityNational Pollen and Aerobiology Unit, WorcesterCompletedGrass Pollen Ocular AllergyUnited Kingdom
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Laboratorios Leti, S.L.CompletedAllergy to Grass Pollen (Dactylis Glomerata)Spain
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Laboratorios Leti, S.L.CompletedAllergy to Grass Pollen (Secale Cereale)Spain
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MacroArray Diagnostics GmbHCompletedCat Allergy | Grass Pollen Allergy | Birch Pollen Allergy | House Dust Mite Allergy | Bee Venom Allergy | Vespid Venom AllergyAustria
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Biomay AGCompletedGrass Pollen AllergyAustria, Belgium, Denmark, Germany, Netherlands, Slovenia
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Biomay AGCompletedGrass Pollen AllergyAustria
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Allergopharma GmbH & Co. KGCompletedGrass Pollen AllergyGermany
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ALK-Abelló A/SCompletedGrass Pollen AllergyDenmark
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