Grass Pollen Subcutaneous Immunotherapy in Elderly Patients (SCITelderly)
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|ClinicalTrials.gov Identifier: NCT02440243|
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Background There is limited evidence indicating that specific immunotherapy in elderly patients is safe and effective. This study was performed to evaluate the safety and efficacy of specific subcutaneous immunotherapy (SCIT) against grass pollen allergens in patients over 60 years of age with seasonal allergic rhinitis (SAR) and a confirmed allergy to grass pollen.
Objective This study assessed the safety and efficacy of SCIT for grass pollen allergens in elderly patients with SAR.
Methods This study included 62 60- to 75-year-old patients with SAR and grass pollen allergy confirmed using a skin prick test, nasal provocation, and serum IgE measurement. The patients were individually randomized to the active or placebo groups using a double-blinded method. There were 33 subjects in the SCIT group (Purethal, Grass pollen, HAL Allergy B.V, Leiden, Netherlands) and 29 subjects in the placebo group monitored for three years. The patients were required to record each use of anti-allergy medication in a diary and use a visual graphic scale. The main outcome measure was the area under the curve (AUC) for the combined symptom and medication score (SMS).
|Condition or disease||Intervention/treatment||Phase|
|Allergy||Drug: Purethal Drug: Purethal -placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Grass Pollen Subcutaneous Immunotherapy: a Double-blind, Placebo-controlled Study in Elderly Patients With an Allergy to Grass Pollen|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Patients active
prerseasonal course of SCIT - three years
Other Name: Vaccine
Placebo Comparator: Patients placebo
Drug: Purethal -placebo
preseasonal course of SCIT - three years
- The symptoms reduction as a compsite measure [ Time Frame: three years ]The prime outcome measure was the area under the curve (AUC) for combined symptom and medication score (SMS)
- Evaluation of symptomatic medication use reduction [ Time Frame: three years ]Evaluation quantities of drugs based on patient diary.
- Number of patients with a local allergic reaction after injections [ Time Frame: three years ]The local reactions were assessed at 30 min after injection and measured in cm.
- Number of patients with a systemic allergic reaction after injections [ Time Frame: three years ]The systemic reaction were assesed after injection according EAACI criteria.