Should Non-eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- Asthma Control Questionnaire (ACQ) Score After 4 Weeks of Treatment With Inhaled Corticosteroids (ICS) or Placebo
研究概览
简要总结
The efficacy of inhaled corticosteroids (ICS) in asthmatic subjects showing no sputum eosinophils is controversial. The broad aim of this study is to assess whether ICS alone or in combination with long-acting beta-2 agonists are an effective treatment in non-eosinophilic asthmatic subjects. Methods: The investigators will perform a randomized double-blind, placebo-controlled, multicenter study comparing the efficacy of ICS and placebo for 4 weeks followed by a 4-week open treatment period with ICS/salmeterol in steroid-naïve asthmatic subjects without sputum eosinophilia. The primary outcome will be the the Asthma Control Questionnaire (ACQ) score after four weeks of treatment by ICS or placebo.
This study will determine whether or not non-eosinophilic asthmatic subjects respond to ICS and if they further benefit from the addition of a long-acting beta-2 agonists. This study will also determine whether or not the assessment of airway inflammation should be performed in every asthmatic patient in order to give the most appropriate treatment.
详细描述
General objective: To assess whether inhaled corticosteroids alone or in combination with long-acting beta-2 agonists are an effective treatment in non-eosinophilic asthmatic subjects.
Specific objective 1. To compare the change in clinical and functional outcomes after treatment with fluticasone or placebo in non-eosinophilic asthmatic subjects.
Specific objective 2. To assess whether the combination of inhaled corticosteroids (ICS) and with long-acting beta-2 agonists provides an improvement of asthma control compared to the treatment with ICS or placebo in non-eosinophilic asthmatics.
Hypothesis: Treatment with ICS induces a significant clinical and physiologic improvement of non-eosinophilic asthmatic subjects. ICS/Salmeterol also provides a clinical and physiologic benefit compared to placebo.
Primary end point: Asthma Control Questionnaire (ACQ) score after 4 weeks of treatment with ICS or placebo.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are between 18 and 70 years of age at the time of signing the informed consent.
- •Have a diagnosis of asthma according to the Guidelines for the Diagnosis and Management of Asthma and have not been treated with ICS in the previous two months.
- •Have a PC20 methacholine less than 8 mg/ml.
- •Have a baseline FEV1 greater or equal to 65% of predicted value (at least 6 hours after bronchodilator).
- •Are not optimally controlled with short-acting 2 agonists as shown by awakenings due to asthmatic symptoms at least once a week, or regular use of salbutamol on 4 or more occasions per week (excluding exercise prophylaxis) due to asthma symptoms.
- •ACQ score equal or greater than 2
- •Have sputum eosinophils less than 2%
- •Are non smokers or ex-smokers who smoked a maximum of 10 pack/year.
排除标准
- •Hospitalized patients within the last 3 months
- •Current or recent (within the last month) symptoms of a cold or flu
- •Patients with a history of near fatal asthma
- •Subjects on inhaled corticosteroids, prednisone, long-acting beta 2 agonists, montelukast or theophylline, within 2 months prior to entry into the study.
研究组 & 干预措施
Active treatment group (A)
Intervention : treatment with inhaled corticosteroids (Fluticasone) will be administered to this group
干预措施: Fluticasone (Drug)
Control group treated with placebo (B)
treatment with placebo
干预措施: Placebo (sham inhaler) (Drug)
结局指标
主要结局
Asthma Control Questionnaire (ACQ) Score After 4 Weeks of Treatment With Inhaled Corticosteroids (ICS) or Placebo
时间窗: Four weeks
Validated questionnaire assessing asthma control after 4 weeks of treatment with ICS or placebo. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of 7 items and thus ranges between 0 (well controlled) and 6 (extremely poorly controlled) to yield a mean score out of 6. The higher the score, the worst asthma control is.
次要结局
- Asthma Quality of Life Questionnaire (AQLQ) Score After 4 Weeks of Treatment(Four weeks)
- Change in Forced Expiratory Volume in One Second (FEV1)(Four weeks)
- Change in Provocative Concentration of Methacholine Inducing a 20% Fall in FEV1 (PC20)(Four weeks)
研究者
Catherine Lemiere
MD,MSc
Université de Montréal