Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Average Daily Total Combined Score (TCS)
研究概览
简要总结
TX-SMILE is an investigator-initiated, multi-center, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety, and tolerability of intra-lymphatic administration of an approved allergenic extract for the immunotherapy treatment of allergic rhinitis and conjunctivitis due to pollen from the conifer Mountain Cedar.
详细描述
TX-SMILE is an investigator-initiated, multi-center, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety, and tolerability of an alternative injection site and associated adjustments to dosing and treatment regimen for allergen immunotherapy with a commercially-available, FDA-approved allergenic extract for the immunotherapy treatment of allergic rhinitis and conjunctivitis due to pollen from the conifer Mountain Cedar (Juniperus ashei).
The purpose of this study is to evaluate the effect of a three-dose treatment series of ultrasonography-guided, intra-lymphatic immunotherapy injections over a two-month period prior to the start of the 2018-2019 Mountain Cedar allergy season in central Texas. Patients will be evaluated for safety and tolerability during the treatment period and for efficacy during the 2018-2019 Texas Mountain Cedar pollen season.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female adult patients with a history of Season Allergic Rhinitis (SAR) with bothersome symptoms due to Mountain Cedar pollinosis confirmed using the Modified Quantitate Test (MQT; defined as a wheal greater than or equal to 3 millimeters larger than the diluent control)
- •Patients must be willing to provide written, informed consent
- •Patients must be willing and able to comply with study procedures
- •Women of childbearing potential must agree to use an acceptable form of contraception during the trial
排除标准
- •Patients less than 18 years of age
- •Clinically-significant chronic sinusitis, as determined by the investigator
- •History of anaphylaxis during Mountain Cedar skin prick testing
- •Participation in another clinical trial or use of an experimental medication within 30 days of enrollment
- •Medically significant co-morbidities that, in the opinion of the investigator, place the subject at increased risk during the study, including but not limited to:
- •Autoimmune diseases, other than allergic rhinitis (AR), stable allergic asthma, eczema and food sensitivities
- •Pulmonary or respiratory diseases other than stable asthma
- •Cancer other than basal cell carcinoma
- •Coronary artery disease or hypertension treated with beta-blockers
- •Clinically significant impairment of renal or hepatic function
- •Use of concomitant medications that, in the opinion of the investigator, may reduce the effectiveness of rescue treatments for anaphylaxis (e.g. beta-blockers) or alter the immune response to allergen immunotherapy (e.g., immunosuppressants, systemic corticosteroids)
- •Previously completed immunotherapy for Mountain Cedar pollinosis, that in the opinion of the investigator would interfere with the assessment or treatment of the patient
- •Inability to access suitable lymph nodes for intralympahtic injections
- •Plans to leave the area for a significant period of the upcoming Mountain Cedar pollen season
- •Pregnant or lactating females
结局指标
主要结局
Average Daily Total Combined Score (TCS)
时间窗: Up to 4 months
The TCS is the preferred endpoint for rhinoconjunctivitis as recommended by the European Academy of Allergy and Clinical Immunology. Scoring of the TCS is from 0 to 38 on each day that it is assessed. The TCS is the sum of the symptom scores for "runny nose", "stuff nose", "sneezing", "itchy nose", "gritty/itchy eyes", and "watery eyes" rated from no symptoms = 0 to severe symptoms = 3 plus the score for use of rescue medications for allergy symptoms 6 points for oral antihistamine, 6 points for eye drops, and 8 points for a nasal corticosteroid. Thus, a lower score represents fewer symptoms and associated need for allergy medication, while a higher score reflects more severe symptoms and the use of medication to treat symptoms. The TCS will be measured during the 2018-2019 Mountain Cedar pollen se
次要结局
- Patient Reported Pain or Discomfort Following Intra-lymphatic Injections(Immediately after the ILIT procedure)
- Number of Subjects Who: Experienced Anaphylaxis, Were Treated With Epinephrine, or Experienced Any Other Treatment-emergent SAE Within 60 Minutes of Any of Three Planned ILIT Procedures(8 weeks)
- Number of Peak Pollen Season Days With a Lower Group Average Total Combined Score(Assessed up to 4 months, number of actual peak pollen season days was 27)
- Patient-reported Treatment Satisfaction at the End of Study(Up to 4 months)
- Percentage Change in Allergen-specific Serum IgE(Assessed prior to the first injection and to 4-8 weeks after the end of the 2018-2019 pollen season)
- Total Safety Score (TSS) for Active and Placebo Treatment Groups(8 weeks)
研究者
Christopher Thompson, MD
Principal Investigator
Texan Allergy & Sinus Center