NCT01335139已完成2 期
A Randomized, Double-blind, Single-center, Placebo Controlled Study of Sublingual Immunotherapy and Subcutaneous Immunotherapy in Adults With Seasonal Allergic Rhinitis (ITN043AD)
National Institute of Allergy and Infectious Diseases (NIAID)2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2011年3月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Nasal Response to Allergen Challenge
研究概览
简要总结
The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT, grass pollen tablets under the tongue) has long term effects in severe hay fever.
详细描述
This is a randomized, double-blind, single-center, placebo-controlled, three-arm study comparing SLIT with placebo and SCIT with placebo. The main comparison will be between SLIT and placebo.
Individuals with severe grass pollen hay fever, with or without associated seasonal asthma, will be recruited during the pollen season of March through September 2011. Eligible participants will be randomized to one of the following three treatment arms administered in a double-blind (masked), double-dummy fashion in a 1:1:1 ratio:
- SLIT + SCIT placebo
- SCIT + SLIT placebo
- SLIT placebo + SCIT placebo
Participants will receive treatment over a 2-year period followed by a 1-year blinded (masked) withdrawal phase. Participants will be provided with anti-allergic rescue medications (antihistamine, topical intranasal corticosteroids, and short-acting beta agonists) throughout the study. Clinical endpoint assessments will be performed at prior to initiating their assigned treatment, after 1 and 2 years of treatment, and after the 1-year withdrawal period at 3 years.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May, June, or July;
- •A clinical history of moderate to severe rhinoconjunctivitis symptoms interfering with usual daily activities or with sleep as defined according to the Allergic Rhinitis and its Impact on Asthma (ARIA) classification of rhinitis;
- •A clinical history of rhinoconjunctivitis for at least 2 years requiring treatment with either antihistamines or nasal corticosteroids during the grass pollen season;
- •Positive skin prick test response, defined as wheal diameter greater than or equal to 3 mm, to Phleum pratense (e.g., Timothy grass);
- •Positive specific IgE, defined as greater than or equal to IgE class 2 (0.7 kU/L), against Phleum pratense;
- •A positive response to nasal allergen challenge with Phleum pretense, defined as an increase in TNSS greater than or equal to 7 points above baseline;
- •For women of childbearing age, a willingness to use an effective form of contraception for the duration of the trial; and
- •The ability to give informed consent and comply with study procedures.
排除标准
- •Prebronchodilator forced expiratory volume at 1 second (FEV1) less than 70% of predicted value at either screening or baseline visit;
- •A clinical history of moderate to severe allergic rhinitis, according to the ARIA classification, due to tree pollen near or overlapping the grass pollen season;
- •A clinical history of persistent asthma and/or requiring regular inhaled corticosteroids for > 4 weeks per year outside of the grass pollen season;
- •A clinical history of moderate- severe allergic rhinitis, according to the ARIA classification, caused by an allergen to which the participant is regularly exposed;
- •History of emergency visit or hospital admission for asthma in the previous 12 months;
- •History of chronic obstructive pulmonary disease;
- •History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment;
- •History of chronic sinusitis, defined as a sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
- •At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.
- •Any tobacco smoking within the last 6 months or a history of ≥ 10 pack years;
- •Previous treatment by immunotherapy with grass pollen allergen within the previous 5 years.
- •Any history of grade 4 anaphylaxis due to any cause as defined by the World Allergy Organization (WAO) grading criteria for immunotherapy;
- •History of bleeding disorders or treatment with anticoagulation therapy;
- •History of anti-IgE monoclonal antibody treatment;
- •Ongoing systemic immunosuppressive treatment;
- •History of intolerance to the study therapy, rescue medications, or their excipients;
- •For women of childbearing age a positive serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours before the start of study therapy;
- •The use of any investigational drug within 30 days of the screening visit; or
- •The presence of any medical condition that the investigator deems incompatible with participation in the trial.
结局指标
主要结局
Nasal Response to Allergen Challenge
时间窗: 3 years
Defined as the average of the Total Nasal Symptom Score (TNSS) area under the curve (AUC) measured at 0 to 1 hours and the AUC measured at 1 to 10 hours after allergen challenge. The primary outcome consists of the comparison of SLIT + SCIT placebo versus SLIT placebo + SCIT placebo.
次要结局
- Skin Late Phase Response (LPR) to Intradermal Testing(Baseline (Time 0) and 1,-2, and -3 years)
- Hay Fever Severity Score(1, 2 and 3 years)
- Peak Nasal Inspiratory Flow (PNIF) EPR Area Under the Curve (AUC)(Baseline (Time 0) and 1, -2, and -3 years)
- Nasal EPR(Baseline (Time 0) and 1, -2, and -3 years)
- Skin Prick Test Endpoint Titration(Baseline (Time 0) and 1, -2, and -3 years)
- Peak Nasal Inspiratory Flow (PNIF) LPR(Baseline (Time 0) and 1, -2, and -3 years)
- Peak Nasal Inspiratory Flow (PNIF) LPR Area Under the Curve (AUC)(Baseline (Time 0) and 1, -2, and -3 years)
- Use of Rescue Medications During the Pollen Season(1, -2, and -3 years)
- EXPLORATORY: Mechanistic Assessments of Local Immune Responses(1, 2, and 3 years)
- Skin Early Phase Response (EPR) to Intradermal Testing(Baseline (Time 0) and 1, -2, and -3 years)
- Nasal LPR(Baseline (Time 0) and 1, -2, and -3 years)
- Peak Total Nasal Symptom Score (TNSS) EPR(Baseline (Time 0) and 1, -2, and -3 years)
- Mini Rhinoconjunctivitis Quality-of-Life Questionnaire Score(1, -2, and -3 years)
- Weekly Visual Analog Symptom (VAS) Scores(1, -2, and -3 years)
- EXPLORATORY: Mechanistic Assessments of Peripheral Blood Subsets(1, 2, and 3 years)
研究者
研究点 (2)
Loading locations...
相似试验
终止
3 期
Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and ChildrenAllergic Rhinitis Due to Dust MiteNCT01199133Stallergenes Greer471
已完成
不适用
Efficacy of sublingual immunotherapy (SLIT) in asthmatic patients with cedar pollen rhinoconjunctivitisAsthmaJPRN-UMIN000020445Juntendo University Faculty of Medicine and Graduate School of Medicine, Department of respiratory medicine24
已完成
2 期
Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic RhinitisAllergic RhinitisNCT00674700Stallergenes Greer509
已完成
3 期
Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)RhinoconjunctivitisAllergyConjunctivitisRhinitisNCT00562159ALK-Abelló A/S439
已完成
1 期
Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy AdultsHealthyNCT01071889Coeruleus Ltd.10