ACTRN12620001091998进行中（未招募）3 期
An open-label randomised controlled trial of the efficacy and safety of as-needed budesonide-formoterol vs salbutamol reliever therapy in mild childhood asthma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Years 至 15 Years（—）
- 性别
- All
入选标准
- •1) Aged five to 15 years
- •2) Doctor diagnosis of asthma (parent/participant or doctor-reported) AND
- •a.SABA use on greater than or equal to 3 consecutive days in the last 12 months, AND/OR
- •b.SABA use on greater than or equal to 2 days per month, on average, in the last 12 months, AND/OR
- •c.Urgent medical review for worsening asthma in the last 12 months.
- •3. Registered with a General Practitioner
- •; 1) Aged five to 15 years
- •2) Doctor diagnosis of asthma (parent/participant or doctor-reported) AND
- •a.SABA use on greater than or equal to 3 consecutive days in the last 12 months, AND/OR
- •b.SABA use on greater than or equal to 2 days per month, on average, in the last 12 months, AND/OR
- •c.Urgent medical review for worsening asthma in the last 12 months.
- •3. Registered with a General Practitioner
排除标准
- •1) Hospital admission (equal to or greater than 24 hours) for asthma in the last 12 months
- •2) Self-reported use of >6 SABA inhalers in the last 12 months (i.e. poor-control)
- •3) Any use of ICS, LABA, leukotriene receptor antagonist (LTRA), theophylline, anticholinergic agent or cromone in the last 6 months
- •4) Any use of systemic corticosteroids in the last 6 weeks
- •5) Any medical condition which, at the Investigator’s discretion, may present a safety risk or impact the feasibility of the study or the study results (including, but not limited to, other significant respiratory comorbidities, such as cystic fibrosis and bronchiectasis)
- •6) Any known or suspected contraindications to the medications prescribed in the study or their respective excipients
- •7) Previous life-threatening asthma (Intensive Care Unit admission)
- •8) Unable or unwilling to switch from current asthma treatment regimen
- •9) Unable or unwilling to provide written informed consent (parent(s)/guardian(s)) or assent/consent (participant)
- •10) Self-reported current pregnancy or breast feeding at the time of enrolment
- •; 1) Hospital admission (equal to or greater than 24 hours) for asthma in the last 12 months
- •2) Self-reported use of >6 SABA inhalers in the last 12 months (i.e. poor-control)
- •3) Any use of ICS, LABA, leukotriene receptor antagonist (LTRA), theophylline, anticholinergic agent or cromone in the last 6 months
- •4) Any use of systemic corticosteroids in the last 6 weeks
- •5) Any medical condition which, at the Investigator’s discretion, may present a safety risk or impact the feasibility of the study or the study results (including, but not limited to, other significant respiratory comorbidities, such as cystic fibrosis and bronchiectasis)
- •6) Any known or suspected contraindications to the medications prescribed in the study or their respective excipients
- •7) Previous life-threatening asthma (Intensive Care Unit admission)
- •8) Unable or unwilling to switch from current asthma treatment regimen
- •9) Unable or unwilling to provide written informed consent (parent(s)/guardian(s)) or assent/consent (participant)
- •10) Self-reported current pregnancy or breast feeding at the time of enrolment
研究者
相似试验
已完成
不适用
A study comparing the efficacy of clindamycin plus quinine with coartem for treating Kenyan children with uncomplicated falciparum malariaMalariaPACTR201209000419241Kenya Medical Research Institute384
尚未招募
3 期
A study on the effect of Ayurvedic complementary food.CTRI/2023/06/053488il
已完成
不适用
An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitustype 2 diabetes mellitusJPRN-UMIN000025122Kanagawa-ken Keiyu-kai Keiyu hospital20
已完成
不适用
Open-labelled randomized controlled trial of the effect of PDA-based self-care system for type 2 diabetes versus usual care.type II DMJPRN-UMIN000002992Stress Science and Psychosomatic Medicine, Graduate School of Medicine, The University of Tokyo30
招募中
2 期
Open label, comparative, randomized trial of the efficacy, safety and bioavailability of highly concentrated inhalative epinephrine (4 mg L-Epinephrin/ml, Infectokrupp® Inhal) versus Epinephrin-Autoinjektor-Anwendung (Fastjekt® Junior) in infants with acute anaphylactic reaction in the course of a food challengeT78.0Anaphylactic shock due to adverse food reactionDRKS00011881Charité Campus Virchow-Klinikum40