NCT03028350已完成2 期
A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)
Cumberland Pharmaceuticals16 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年7月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 16
- 主要终点
- Change From Baseline in Sinonasal Outcome Test-22 Score
研究概览
简要总结
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.
详细描述
This is a randomized, placebo-controlled, double-blind phase 2 trial evaluating approximately 76 subjects with symptomatic AERD on the safety and efficacy of 8 weeks of oral ifetroban treatment. Eligible AERD subjects will be randomized to receive 8 weeks of either oral ifetroban daily or matching placebo followed by a 2-week post-treatment period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •History of physician-diagnosed asthma
- •History of nasal polyposis
- •History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or one reaction that was life-threatening and required hospitalization, or a diagnosis of AERD by a physician-conducted challenge to aspirin in the last five years before starting treatment.
- •Stable asthma (post-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 60%, no glucocorticoid burst for at least two weeks prior to starting treatment, no hospitalizations or emergency room visits for asthma at least three months prior to starting treatment and not on a dose >1000 µg fluticasone or equivalent daily).
- •≥ 18 years of age
- •Exhibit symptomatic AERD within three weeks of starting treatment by demonstrating a score of at least 20 on the Sino-nasal Outcome Test (SNOT) - 22.
排除标准
- •Current smoking, defined as daily tobacco smoking in the last six months and at least one instance of tobacco smoking in the last three months.
- •Current pregnancy or breastfeeding
- •Use of oral or systemic steroids (e.g. prednisone or equivalent) > 20 mg daily in the last four weeks before starting treatment.
- •Daily use of long-acting antihistamines in the last two weeks before starting treatment.
- •Less than 12 months of allergy shots (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months). Less than 1 month of 5-lipoxygenase inhibitors (e.g. zileuton) and/or leukotriene receptor antagonists (e.g. montelukast).
- •Any use of nonsteroidal anti-inflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme in the last two weeks before starting treatment.
- •History of bleeding diathesis or use of anticoagulant or antiplatelet drugs in the last two weeks before starting treatment.
- •Any immunosuppressive treatment including but not limited to methotrexate, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, and cyclophosphamide in the last two weeks before starting treatment (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months). Biologics/immunotherapies such as Xolair or Nucala are permitted if duration exceeds three months.
- •Endoscopic sinus surgery / polypectomy within the past three months
- •Previously treated in a clinical trial with ifetroban within the past three months.
- •Previously treated with other investigational drugs within eight weeks or five half-lives, whichever is longer, before screening
- •Conditions/concomitant disease which make them unevaluable for the efficacy endpoints
研究组 & 干预措施
Ifetroban Oral Capsule
Experimental
Oral ifetroban, 200 mg daily for 8 weeks
干预措施: Ifetroban Oral Capsule (Drug)
Placebo Oral Capsule
Placebo Comparator
Oral placebo daily for 8 weeks
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Change From Baseline in Sinonasal Outcome Test-22 Score
时间窗: Baseline and 8 weeks
Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.
次要结局
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Baseline and 8 weeks)
- Change From Baseline in Asthma Control Questionnaire -7 Score(Baseline and 8 weeks)
- Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)(Baseline and 8 weeks)
- Change From Baseline in Total Nasal Symptom Score (Afternoon/Evening)(Baseline and 8 weeks)
- Change From Baseline in Total Nasal Symptom Score (Morning)(Baseline and 8 weeks)
- Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR)(Baseline and 8 weeks)
研究者
研究点 (16)
Loading locations...
相似试验
撤回
2 期
A Phase 2 Study With CC-220 in Skin SarcoidosisSarcoidosisNCT02192489Celgene
已完成
2 期
Eltrombopag for Treatment of Fanconi AnemiaFanconi AnemiaNCT06045052Julian Sevilla8
招募中
2 期
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma PatientsDLBCLNCT06569485Sun Yat-sen University38
招募中
2 期
A Trial to Compare Ibrutinib Versus Lenalidomide in Combination With MRE-chemotherapy for Adult Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL)Recurrent/RefractoryPrimary Central Nervous System Lymphoma (PCNSL)NCT04129710Second Affiliated Hospital, School of Medicine, Zhejiang University120
已完成
3 期
A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity DiseaseObesityNCT05931380Eli Lilly and Company238