Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
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
1 other identifier
interventional
154
1 country
1
Brief Summary
The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2001
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 8, 2005
CompletedFirst Posted
Study publicly available on registry
December 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJune 5, 2014
June 1, 2014
2.5 years
December 8, 2005
June 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom and Medication Score
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).
Assessment after the first and second grass pollen season.
Secondary Outcomes (1)
Rhinoconjunctivitis Quality-of-Life Questionnaire
First and second grass pollen season
Study Arms (2)
Allergovit 6-grasses immunotherapy
EXPERIMENTALSeven 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.
Placebo
PLACEBO COMPARATORPlacebo 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.
Interventions
Subcutaneous injections
Eligibility Criteria
You may qualify if:
- Positive Skin Prick test to grass pollen
- Positive RAST to grass pollen
- Positive specific provocation test to grass pollen
You may not qualify if:
- Serious chronic diseases
- Other perennial allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Allergopharma GmbH & Co. KG
Reinbek, 21465, Germany
Related Publications (2)
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.
PMID: 15876311RESULTWilliams 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.
PMID: 17523386RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Annemie Narkus, M.D.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2005
First Posted
December 9, 2005
Study Start
November 1, 2001
Primary Completion
May 1, 2004
Study Completion
August 1, 2010
Last Updated
June 5, 2014
Record last verified: 2014-06