Back to resultsSafety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
Primary Purpose
Grass Pollen Allergy
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Grass pollen formulation
Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Grass Pollen Allergy focused on measuring Sublingual immunotherapy, Rhinoconjunctivitis, Rhinitis, Asthma
Eligibility Criteria
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
Sites / Locations
- Allergopharma GmbH & Co. KG
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Liquid formulation of an extract of a 6 grass pollen mixture
Arm Description
Placebo was given the same way as a sublingual preparation.
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.
Outcomes
Primary Outcome Measures
Symptom and Medication Score (SMS)
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 Outcome Measures
Visual Rating Scale
Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)
Full Information
NCT ID
NCT00264459
First Posted
December 12, 2005
Last Updated
January 23, 2014
Sponsor
Allergopharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00264459
Brief Title
Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grass Pollen Allergy
Keywords
Sublingual immunotherapy, Rhinoconjunctivitis, Rhinitis, Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was given the same way as a sublingual preparation.
Arm Title
Liquid formulation of an extract of a 6 grass pollen mixture
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
Grass pollen formulation
Other Intervention Name(s)
specific immunotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Comparator
Other Intervention Name(s)
Specific Immunotherapy
Intervention Description
Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
Primary Outcome Measure Information:
Title
Symptom and Medication Score (SMS)
Description
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.
Time Frame
1.5 years of therapy
Secondary Outcome Measure Information:
Title
Visual Rating Scale
Description
Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludger Klimek, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergopharma GmbH & Co. KG
City
Reinbek
ZIP/Postal Code
21465
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17274520
Citation
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.
Results Reference
result
PubMed Identifier
18426146
Citation
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.
Results Reference
result
Links:
URL
http://www.allergopharma.de
Description
Leader in specific allergy research and therapy
Learn more about this trial
Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
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