Low Exhaled NO and ICS in Suspected Asthma (LowNO)
Does a Low Exhaled Nitric Oxide Level Exclude a Clinical Benefit From Inhaled Corticosteroids in Suspected Asthma: A Randomised, Placebo Controlled Trial
研究概览
详细说明
At the first visit, which will take place at either at the GP surgery or the Nottingham Respiratory Research Unit (NRRU) informed written consent for the study will be obtained. The patients will then have an exhaled NO measurement, spirometry, venepuncture (for Full Blood Count and research blood - if consent obtained) taken and complete an Asthma Control Questionnaire (ACQ), Medical Research Council dyspnoea scale (MRC) and Leicester Cough Questionnaire (LCQ). All procedures will be carried out by the NRRU research nurse.
The investigators may use the NRRU existing database of research volunteers to recruit as necessary and also the respiratory clinics held at the NUH. If patients from clinics are recruited they will be initially approached by their usual care doctor and an information sheet will be sent / given to them accordingly.
If all the inclusion criteria are met and none of the exclusion criteria, the patients will be randomised to receive either a placebo inhaler, to be taken one puff twice daily, or a low dose inhaled steroid treatment, Budesonide 200mcgs via Turbuhaler one puff twice daily, for 3 months. Dr Tim Harrison will be prescribing the inhalers and they will be dispensed from the Nottingham City Hospital Clinical Trials Pharmacy and delivered/given to the patient by the research nurses.
Participants will be asked to return for follow up visits at 4 weeks, 8 weeks and 12 weeks following randomisation. At these follow up visits, exhaled NO, spirometry and the 3 questionnaires will be repeated.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Tim Harrison, MD
- 邮箱：tim.harrison@nottingham.ac.uk
研究联系人备份
- 姓名：Angela Shone
- 邮箱：angela.shone@nottingham.ac.uk
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 18 years or over.
- Asthma suspected by GP/Practice Nurse
- Must be able to give informed consent
- Exhaled Nitric Oxide reading <27ppb
- FEV1 >70% predicted
Exclusion Criteria:
- Patients requiring oral steroid treatment on visit to GP/Practice nurse
- Use of oral prednisolone or antibiotics within last 4 weeks
- Already using an inhaled corticosteroid
- Any other clinically significant co-morbidity.
- Expectant or breast feeding mothers.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Budesonide (Pulmicort)
Low dose inhaled corticosteroid.
|
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
|
|
安慰剂比较：Placebo - dummy inhaler
|
Placebo - dummy inhaler to be taken 1 puff twice daily.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in Asthma Control Questionnaire (ACQ-7) between the inhaled steroid and placebo group adjusted for differences in baseline. The ACQ will measure the level of asthma control in the ICS and placebo group.
大体时间：overall 12 weeks
|
Data will be collect via questionnaire at each visit.
A change in ACQ-7 of 0.5 is considered clinically important.
|
overall 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.
大体时间：overall 12 weeks
|
FEV1 will be measured in Litres.
|
overall 12 weeks
|
|
Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline.
大体时间：overall 12 weeks
|
A minimal important difference in LCQ is 1.3.
This will be assessed using this validated, self-reported measure of quality of life for cough.
|
overall 12 weeks
|
|
Difference in a subjective measurement of MRC dyspnoea scale.
大体时间：overall 12 weeks
|
This is a subjective scale of breathlessness graded 1-5 (5 being most breathless).
This will be assessed from baseline measurements.
|
overall 12 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The incidence of asthma exacerbations will be recorded for each group and compared.
大体时间：12 weeks
|
The number of asthma exacerbations will be captured from verbal feedback from specific patient questioning at study visits.
|
12 weeks
|
|
The deterioration in asthma control as measured by ACQ-7 and compared between groups.
大体时间：12 weeks
|
deterioration in asthma control will be captured from the ACQ- 7
|
12 weeks
|
合作者和调查者
调查人员
- 首席研究员：Tim Dr Harrison, MD、University of Nottingham
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Budesonide (Pulmicort)的临床试验
-
Bond Avillion 2 Development LP完全的
-
Milton S. Hershey Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)完全的
-
Vectura Limited完全的