ACTRN12622001304729进行中（未招募）4 期
An open-label randomised controlled trial investigating the effect of as-needed budesonide-formoterol vs terbutaline reliever therapy on airways inflammation in adults with mild-moderate asthma on inhaled corticosteroid maintenance therapy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 181
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
- 16 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Aged 16 to 75 years
- •- Self-reported doctor’s diagnosis of asthma for >/= 6 months prior to visit 1
- •- Current use (within the last 3 months) of either:
- •Inhaled corticosteroid (ICS) maintenance (any dose) plus a short-acting beta-agonist (SABA) reliever inhaler OR
- •SABA reliever inhaler only OR
- •ICS/LABA combination reliever inhaler only
- •- Average use of SABA reliever on >/= 2 episodes per week, over the last 12 weeks
- •- FeNO >/= 25 ppb at screening
- •- Ability to perform FeNO measurements at home on a regular basis
- •- Ability to use the turbuhaler device
- •- Self-reported registered with a General Practitioner
排除标准
- •- Current use (within the last 3 months) of other asthma medications including: ICS/long-acting beta-agonist (LABA) combination inhalers, leukotriene receptor antagonists, theophylline, regular oral corticosteroids, sodium cromoglycate or anticholinergic agents
- •- Average use of ICS/LABA combination reliever inhaler on = 8 episodes per week, over the last 12 weeks
- •- Any use of systemic corticosteroids in the last 6 weeks
- •- Self-reported diagnosis of COPD, bronchiectasis, vocal cord dysfunction or interstitial lung disease
- •- Self-reported current smokers, defined as someone who has smoked more than 100 cigarettes (including hand rolled cigarettes, cigars, cigarillos, etc), or has used an e-cigarette on more than 100 occasions in their lifetime, and has smoked or vaped in the last 28 days
- •- Self-reported greater than 20 pack year smoking history, or asthma diagnosis after the age of 40 years in current or ex-smokers with >/=10 pack year history
- •- Self-reported congestive heart failure, atrial fibrillation, unstable coronary artery disease, or other clinically significant cardiac disease
- •- 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
- •- Any known or suspected contraindications to the medications prescribed in the study or their respective excipients
- •- Previous life-threatening asthma (Intensive Care Unit admission for asthma ever)
- •- Unable or unwilling to switch from current asthma treatment regimen
- •- Unable or unwilling to provide written informed consent
- •- Self-reported current or planned pregnancy or breast feeding at the time of enrolment
- •- Self-report of participation in another research trial involving an unapproved investigational medicinal product, in the past 12 weeks
研究者
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