- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00263601
Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
June 4, 2014 updated by: Allergopharma GmbH & Co. KG
A Multicentre, Placebo Controlled, Double-Blind Study for Evaluation of Safety and Efficacy of Preseasonal Specific Immunotherapy With an Allergoid Preparation of an Extract of a 6 Grass Pollen Mixture in Patients With Clinically Relevant Grass Pollen Sensitivity
The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pollen allergoids are prepared by chemical modification of partially purified native allergen aqueous extracts that have been depleted of components with a molecular mass of less than 5000 Daltons by diafiltration.
Clinical studies have shown a good tolerance of aqueous grass, ragweed and tree pollen allergoids in comparison with allergen preparations.
Adsorption of pollen allergoids onto aluminium hydroxide suspensions results in depot preparations which have been investigated in a series of clinical studies and shown to be well tolerated with good clinical efficacy.
Depot pollen-allergoids were introduced into the German market in 1987 under the trade name Allergovit® and are now firmly established and recommended primarily for shortcourse preseasonal immunotherapy in pollinosis.
Allergovit® is currently available in many European and non-European countries.
A placebo-controlled study design was chosen as improvements in the symptoms of pollen allergies can not be shown over time, as pollen seasons of different years are not comparable.
Due to the different mechanisms of action, specific immunotherapy can not be compared with anti-allergic drugs.
Thus the only chance to prove efficacy for specific immunotherapy (SIT) is to test versus a parallel placebo group.
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Reinbek, Germany, 21465
- Allergopharma GmbH & Co. KG
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Positive Skin Prick test to grass pollen
- Positive RAST to grass pollen
- Positive specific provocation test to grass pollen
Exclusion Criteria:
- Serious chronic diseases
- Other perennial allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
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Experimental: Allergovit 6-grasses immunotherapy
Seven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season.
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Subcutaneous injections
Other Names:
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Placebo Comparator: Placebo
Placebo injections was given the same way: Seven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season.
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Subcutaneous injections
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom and Medication Score
Time Frame: Assessment after the first and second grass pollen season.
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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).
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Assessment after the first and second grass pollen season.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rhinoconjunctivitis Quality-of-Life Questionnaire
Time Frame: First and second grass pollen season
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Changes in the scores of Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ by E Juniper) at baseline (outside the grass pollen season), every two weeks during the 3 months grass pollen season (year 1+2).
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First and second grass pollen season
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Annemie Narkus, M.D.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Corrigan CJ, Kettner J, Doemer C, Cromwell O, Narkus A; Study Group. Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid. Allergy. 2005 Jun;60(6):801-7. doi: 10.1111/j.1398-9995.2005.00790.x.
- Williams A, Henzgen M, Rajakulasingam K. Additional benefit of a third year of specific grass pollen allergoid immunotherapy in patients with seasonal allergic rhinitis. Eur Ann Allergy Clin Immunol. 2007 Apr;39(4):123-6.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Primary Completion (Actual)
May 1, 2004
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
December 8, 2005
First Submitted That Met QC Criteria
December 8, 2005
First Posted (Estimate)
December 9, 2005
Study Record Updates
Last Update Posted (Estimate)
June 5, 2014
Last Update Submitted That Met QC Criteria
June 4, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Al0101av
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
Clinical Trials on Allergovit 6-grasses
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Allergopharma GmbH & Co. KGInflamax Research IncorporatedTerminatedHealthy Volunteers | Allergic RhinoconjunctivitisCanada
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Royal Sussex County HospitalUnknownOral Allergy SyndromeUnited Kingdom
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HAL AllergyCompletedRhinitis, Allergic, Seasonal | Conjunctivitis, AllergicGermany, Poland, Belgium, Netherlands
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Ministry of Science and Higher Education, PolandCompletedSeasonal Allergic Rhinitis | ImmunotherapyPoland
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HAL AllergyCompleted
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University of ZurichZentrums für Rhinologie und Allergologie WiesbadenCompletedAllergic RhinitisSwitzerland
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Royal Sussex County HospitalTerminated
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Karolinska InstitutetKarolinska University Hospital; Skane University HospitalCompletedAllergic RhinitisSweden
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Laboratorios Leti, S.L.CompletedAllergy | Rhinitis | Rhinoconjunctivitis | Seasonal AsthmaSpain
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Medical University of LodzAllergopharma GmbH & Co. KGCompletedSeasonal Allergic RhinitisPoland