Randomized Trial Assessing the Effectiveness of Beclomethasone and Combination Beclomethasone and Salbutamol as Compared With Placebo in Preschool Aged Children With Wheeze
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduce unplanned-symptomatic visits to clinicians
研究概览
简要总结
The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose is to determine the feasibility of a randomized trial designed to determine if either inhaled beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are superior to placebo in treating pre-school aged children with an acute wheezing episode.
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
- 12 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 12-60 months of age
- •wheeze on auscultation
- •mild respiratory distress as measured by a score of < 3 on the Pediatric Respiratory Assessment Measure (PRAM)
- •discharged home after evaluation by their ED physician.
排除标准
- •treatment with oral or parenteral corticosteroids in the last 14 days
- •treatment with more than 2 doses of inhaled corticosteroids in the previous seven days
- •presence of a severe co-morbidity such as bronchopulmonary dysplasia, cystic fibrosis, congenital heart disease, adrenal disorder or immune deficiency
- •previously enrolled into this study or concurrently enrolled in another intervention trial
- •lack of telephone access or presence of a significant language barrier
研究组 & 干预措施
Placebo
placebo (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.
干预措施: Placebo (Drug)
beclomethasone
beclomethasone dipropionate 250mcg per puff per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.
干预措施: Beclomethasone (Drug)
beclomethasone
beclomethasone dipropionate 250mcg per puff per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.
干预措施: Aerochamber Max® (Device)
beclomethasone and salbutamol
beclomethasone diprionate 250mcg and salbutamol 100mcg per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.
干预措施: Beclomethasone and Salbutamol (Drug)
beclomethasone and salbutamol
beclomethasone diprionate 250mcg and salbutamol 100mcg per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.
干预措施: Aerochamber Max® (Device)
Placebo
placebo (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc.
干预措施: Aerochamber Max® (Device)
结局指标
主要结局
Reduce unplanned-symptomatic visits to clinicians
时间窗: After enrolment is complete
次要结局
- Reduce the number of days with respiratory symptoms(Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days)
- Reduce the need for rescue salbutamol use(Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days)
- Reduce hospitalization rates of target population(Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days)
- Reduce overall societal health care costs of target population(Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days)
研究者
David W Johnson
Professor, Departments of Pediatrics, Pharmacology & Physiology
University of Calgary