Does a Low Exhaled Nitric Oxide Level Exclude a Clinical Benefit From Inhaled Corticosteroids in Suspected Asthma: A Randomised, Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 165
- 主要终点
- 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.
研究概览
简要总结
The purpose of this study is to determine whether a low exhaled nitric oxide reading (<27ppb) is a good predictor of a negative response to inhaled steroid treatment for patients with symptoms suggestive of asthma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Budesonide (Pulmicort)
Low dose inhaled corticosteroid.
干预措施: Budesonide (Pulmicort) (Drug)
Placebo - dummy inhaler
Placebo - dummy inhaler
干预措施: Placebo - dummy inhaler (Drug)
结局指标
主要结局
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.
时间窗: overall 12 weeks
Data will be collect via questionnaire at each visit. A change in ACQ-7 of 0.5 is considered clinically important.
次要结局
- Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline.(overall 12 weeks)
- Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.(overall 12 weeks)
- Difference in a subjective measurement of MRC dyspnoea scale.(overall 12 weeks)