Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
|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|
|Primary Completion Date :||May 2004|
|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).
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.|