NCT01066416终止不适用
Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Asthma Control Score
研究概览
简要总结
It is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. This is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone.
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
- None
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
- •Inclusion criteria: General
- •18 years of age or older
- •Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status
- •Informed consent and ability to comply with study procedures
- •Patients must meet inclusion criteria for both asthma and sinus disease.
- •Inclusion criteria: Asthma
- •In order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria:
- •Diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in FEV1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of >12% and at least 200ml in either FEV1 or FVC, following administration of a short-acting, inhaled bronchodilator).
- •Asthma Control Questionnaire score > 1.5 or
- •Use of inhaled rescue ß-agonist >/= 16 puffs per week (excluding use as a pre-medication for exercise; 1 nebulizer treatment = 2 puffs of inhaler) at any time during the past month or
- •>1 hospitalization or unscheduled MD visit in the past 6 months for asthma symptoms or
- •>1 course of oral steroid use in past 6 months or
- •> 2 weeks of systemic steroids in last 6 months.
排除标准
- •Current smokers or those with at least a 10 pack-year smoking history
- •Presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk
研究组 & 干预措施
Medical therapy
Placebo Comparator
Patients undergo surgery 6 months after randomization
干预措施: medical therapy (Other)
Surgery
Experimental
Patients undergo surgery at time of randomization
干预措施: Endoscopic Sinus Surgery (Procedure)
结局指标
主要结局
Asthma Control Score
次要结局
未报告次要终点
研究者
研究点 (2)
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