Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
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|ClinicalTrials.gov Identifier: NCT00263601|
Recruitment Status : Completed
First Posted : December 9, 2005
Last Update Posted : June 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Grass Pollen Allergy||Biological: Allergovit 6-grasses Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||May 2004|
|Actual Study Completion Date :||August 2010|
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.
Biological: Allergovit 6-grasses
Other Name: Specific immunotherapy with an allergoid preparation.
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.
Other Name: Comparator
- Symptom and Medication Score [ Time Frame: Assessment after the first and second grass pollen season. ]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).
- Rhinoconjunctivitis Quality-of-Life Questionnaire [ Time Frame: First and second grass pollen season ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263601
|Allergopharma GmbH & Co. KG|
|Reinbek, Germany, 21465|
|Principal Investigator:||Annemie Narkus, M.D.|