The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 19
- 主要终点
- Treatment Failure
研究概览
简要总结
This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.
详细描述
This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of controller therapy without loss of asthma control. Patients demonstrating good control on twice-daily low-dose ICS will be randomized to one of three treatment groups: once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or once-daily combination therapy (fluticasone-salmeterol).
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physician-diagnosed asthma
- •age 6 or older
- •pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted
- •beta-agonist reversibility OR airways hyperreactivity by methacholine challenge
- •Juniper Asthma Control Score of 1.5 or greater if not on daily controller
- •good current health
排除标准
- •current or past smoking (greater than 20 pack-years)
- •chronic or current oral steroid therapy
- •pregnancy, lack of effective contraception (when appropriate), lactation
研究组 & 干预措施
Fluticasone
Participants continued fluticasone (100 microgram twice daily) treatment.
干预措施: fluticasone (Drug)
Fluticasone
Participants continued fluticasone (100 microgram twice daily) treatment.
干预措施: montelukast (Drug)
Fluticasone
Participants continued fluticasone (100 microgram twice daily) treatment.
干预措施: Fluticasone plus salmeterol (Drug)
Montelukast
Participants were changed to Montelukast (5 or 10 mg each night).
干预措施: fluticasone (Drug)
Montelukast
Participants were changed to Montelukast (5 or 10 mg each night).
干预措施: montelukast (Drug)
Montelukast
Participants were changed to Montelukast (5 or 10 mg each night).
干预措施: Fluticasone plus salmeterol (Drug)
Fluticasone plus salmeterol
Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
干预措施: fluticasone (Drug)
Fluticasone plus salmeterol
Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
干预措施: montelukast (Drug)
Fluticasone plus salmeterol
Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
干预措施: Fluticasone plus salmeterol (Drug)
结局指标
主要结局
Treatment Failure
时间窗: 16 weeks
The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.
次要结局
未报告次要终点