The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions: A Double Blind Randomized Control Trial.
试验速览
- 阶段
- 1 期
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Immediate Reaction Rate of Build-Up Phase in Pollen Season
研究概览
简要总结
Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a patient receives frequent, escalating doses of the allergens they are allergic to until they reach a predetermined maintenance dose. This is followed by a maintenance phase during which the allergen dose is kept constant and administered at greater intervals. Maximum clinical improvement is generally not seen until a patient is in the maintenance phase. Anecdotal evidence of possible reactions to SCIT administered during a patient's pollen season has led to dosage freezes during a patient's pollen season which extends the length of the build-up phase by many months. Prolonging the buildup phase increases the time required to obtain maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy due to the prolonged period of time when frequent injections are required.
The aims of this study are to determine if adverse reactions to pollen SCIT are increased if doses are increased during pollen season.
详细描述
Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a patient receives frequent, escalating doses of the allergens they are allergic to until they reach a predetermined maintenance dose. This is followed by a maintenance phase during which the allergen dose is kept constant and administered at greater intervals. Maximum clinical improvement is generally not seen until a patient is in the maintenance phase. Anecdotal evidence of possible reactions to SCIT administered during a patient's pollen season has led to dosage freezes during a patient's pollen season which extends the length of the build-up phase by many months. Prolonging the buildup phase increases the time required to obtain maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy due to the prolonged period of time when frequent injections are required.
The aims of this study are to determine if adverse reactions to pollen SCIT are increased if doses are increased during pollen season.
Specific Aim 1: To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of immediate reactions in comparison to holding SCIT doses constant.
Hypothesis: There will not be an increased rate of immediate reactions to SCIT in build up phase received during the pollen season in comparison to SCIT held for pollen season.
Strategy: In a prospective trial, 245 subjects will be randomized to receive monthly (doses held constant) or weekly (doses built up) injections. Rate of immediate local and systemic reactions per injection will be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •include individuals ages 5 and greater at Allergy/Immunology Associates, Inc., who are receiving build-up SCIT to tree, grass, and/or weed pollens for allergic rhinitis, allergic conjunctivitis, and/or asthma
排除标准
- •are in maintenance phase of SCIT
- •are on beta-blockers
- •have a forced expiratory volume in 1 second (FEV1) of less than 70% of predicted
- •have a history of anaphylaxis with previous SCIT to aeroallergens (as defined by the requirement of intramuscular or subcutaneous epinephrine for treatment of a SCIT-induced reaction)
- •have any uncontrolled cardiac or pulmonary disease as determined by their treating allergist/immunologist
- •are pregnant, due to risk of harm to fetus if anaphylaxis occurs.
研究组 & 干预措施
Allergen(Tree, Grass, Weeds) -Held
Allergen(Tree, Grass, Weeds)-Held
Weekly administration of Greer manufactured allergen extract at same dose and concentration patient was on prior to allergen season for the duration of patients allergen season.
干预措施: Allergen(Tree, Grass, Weeds) (Drug)
Allergen(Tree, Grass, Weeds) -Build-up
Allergen(Tree, Grass, Weeds) -Build-up
Weekly administration of Greer manufactured allergen extract at escalating dose and concentration patient for the duration of patients allergen season.
干预措施: Allergen(Tree, Grass, Weeds) (Drug)
结局指标
主要结局
Immediate Reaction Rate of Build-Up Phase in Pollen Season
时间窗: 1 year
To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of immediate reactions in comparison to holding SCIT doses constant.
次要结局
- Delayed Reaction Rate of Build-Up Phase during Pollen Season(1 year.)
研究者
Devi Jhaveri
Principal Investigator
University Hospitals Cleveland Medical Center