Steroids In Eosinophil Negative Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 24
- 主要终点
- Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1.
研究概览
简要总结
Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.
详细描述
SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed asthma for at least previous 12 months.
- •Able to perform reproducible spirometry.
- •Baseline FEV1≥70% of predicted.
- •Asthma confirmed either by:
- •Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR
- •Methacholine PC20 ≤ 16 mg/ml
- •At least 1 of the following indications for chronic controller therapy:
- •Asthma Symptoms > 2 days/week OR
- •Nocturnal Asthma Symptoms > 2 nights/month OR
- •Short-acting beta-agonist use for symptom control > 2 days/week
- •For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.
- •Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.
排除标准
- •Chronic inhaled or oral corticosteroid therapy.
- •Use of inhaled or oral corticosteroid therapy within 6 weeks.
- •New allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen.
- •Use of omalizumab within 3 months.
- •History of:
- •bladder-neck obstruction, urinary retention or benign prostatic hyperplasia
- •narrow angle glaucoma
- •significant cardiovascular disorders and arrhythmias
- •life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years
- •Respiratory tract infection within past 6 weeks.
- •History of smoking within the past 1 year, or > 10 pack-years total if ≥ 18 years of age, or > 5 pack-years total if < 18 years of age.
- •Chronic diseases or medical conditions (other than asthma) that could put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.
研究组 & 干预措施
Mometasone then Tiotropium then Placebo
Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo
干预措施: Mometasone 220mcg BID (Drug)
Mometasone then Tiotropium then Placebo
Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo
干预措施: Tiotropium Respimat 5mcg QD (Drug)
Mometasone then Tiotropium then Placebo
Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo
干预措施: Placebo (Drug)
Mometasone then Placebo then Tiotropium
Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD
干预措施: Mometasone 220mcg BID (Drug)
Mometasone then Placebo then Tiotropium
Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD
干预措施: Tiotropium Respimat 5mcg QD (Drug)
Mometasone then Placebo then Tiotropium
Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD
干预措施: Placebo (Drug)
Placebo then Mometasone then Tiotropium
Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD
干预措施: Mometasone 220mcg BID (Drug)
Placebo then Mometasone then Tiotropium
Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD
干预措施: Tiotropium Respimat 5mcg QD (Drug)
Placebo then Mometasone then Tiotropium
Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD
干预措施: Placebo (Drug)
Placebo then Tiotropium then Mometasone
Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID
干预措施: Mometasone 220mcg BID (Drug)
Placebo then Tiotropium then Mometasone
Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID
干预措施: Tiotropium Respimat 5mcg QD (Drug)
Placebo then Tiotropium then Mometasone
Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID
干预措施: Placebo (Drug)
Tiotropium then Placebo then Mometasone
Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID
干预措施: Mometasone 220mcg BID (Drug)
Tiotropium then Placebo then Mometasone
Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID
干预措施: Tiotropium Respimat 5mcg QD (Drug)
Tiotropium then Placebo then Mometasone
Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID
干预措施: Placebo (Drug)
Tiotropium then Mometasone then Placebo
Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo
干预措施: Mometasone 220mcg BID (Drug)
Tiotropium then Mometasone then Placebo
Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo
干预措施: Tiotropium Respimat 5mcg QD (Drug)
Tiotropium then Mometasone then Placebo
Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1.
时间窗: End of 12-week treatment period
This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.
次要结局
- Peak Expiratory Flow Rate(End of 12-week treatment period)
- Treatment Failure(End of 12-week treatment period)
- Annualized Asthma Control Days(End of 12-week treatment period)
- Forced Expiratory Volume at One Second (FEV1) Percent of Predicted(End of 12-week treatment period)
- Asthma Exacerbations(End of 12-week treatment period)
研究者
dave mauger
Principal Investigator, AsthmaNet Data Coordinating Center
Milton S. Hershey Medical Center