The Effect of HFA - Beclomethasone Dipropionate - Qvar - on Bronchial Hyperreactivity in Preschool Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Adenosine Challenge Test
研究概览
简要总结
Respiratory diseases including Asthma are high prevalent among preschool children. Specific treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the amount of the drug reaching small airways and lungs is bigger how much smaller the particles liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg, that is supposed to reach the small airways at higher concentrations and be more suitable to patients who don't cooperate properly to the procedure of inhalation.
The investigators' group has reported successfully the possibility to perform Pulmonary Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported relation between asthma control and reduction in airway hyperreactivity. The purpose of this study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways hyperreactivity in preschool children, as demonstrated by adenosine challenge test.
详细描述
26 - 30 patients, between 3 -6 years old, mild asthmatics, with positive adenosine challenge test, will received in a randomized, double blind, cross over assignment Beclometasone dipropionate (100µg twice a day) or placebo, through an inhaler (autohaler) device, attached to a spacer device, during four consecutive weeks. Adenosine Challenge test will be performed another time at the end of this four weeks period. After 2 weeks with no medication (wash out period) the patients will receive the second intervention (beclometasone dipropionate or placebo) in a cross over manner and will be submitted to the last adenosine challenge test.
Clinical evaluation, resting spirometry and subjective evaluation through an analogical symptoms scale will be recorded in each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of mild asthma
- •children aged between 3 - 6 years old
- •able to perform spirometry and adenosine challenge test
- •positive challenge test at the time of inclusion
- •without prophylactic treatment for asthma
- •signed informed consent to join the research by the parents or legal tutor
排除标准
- •other chronic diseases
- •use of oral steroids in the last two months
- •emergency room visit in the last two months
- •pneumonia in the last two months
- •impossibility to perform lung function tests
- •disagreement of the parents or legal tutor
研究组 & 干预措施
placebo, adenosine challenge test
Controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceded and succeeded by AMP challenge test,
干预措施: placebo (Drug)
Qvar, adenosine challenge test
Patients will receive 4 weeks of inhale QVAR (HFA beclomethasone) 100µg through a spacer device, twice a day
干预措施: Beclomethasone dipropionate HFA (Drug)
结局指标
主要结局
Adenosine Challenge Test
时间窗: ten weeks
Adenosine challenge test were measured and described as PC 20 - the concentration that corresponded to a FEV1 impairment equal or bigger than 20%. The stage was also recorded
次要结局
未报告次要终点
研究者
l_bentur
Head of pediatric pulmonary institute, Ruth children hospital
Rambam Health Care Campus