EUCTR2015-002384-42-GB进行中（未招募）1 期
Randomised Controlled Trial of the efficacy and safety of an ICS/LABA reliever therapy regimen in asthma. - Novel START (Novel Symbicort Turbuhaler Asthma Reliever Therapy)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 675
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Adults aged 18 to 75 years.
- •2. Self-report of a doctor’s diagnosis of asthma with:
- •a. Self-reported use of a SABA on =2 occasions in the previous 4 weeks but on average =2 occasions per day in the previous 4 weeks, if there have been no severe exacerbations in the last 12 months, or
- •b. Self-reported use of a SABA on average =2 occasions per day in the previous 4 weeks, if there has been a history of a severe exacerbation in the last 12 months.
- •3. Willing and able to give informed consent for participation in the trial.
- •4. In the Investigator’s opinion, able and willing to comply with all trial requirements.
- •5. Willing to allow their General Practitioner and/ or consultant, if appropriate, to be notified of participation in the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 175
排除标准
- •1. Self-reported use of ICS, LABA, leukotriene receptor antagonist, theophylline, anticholinergic agent or cromone as regular maintenance therapy in the 3 months before potential study entry. Note nasal corticosteroid therapy is permitted.
- •2. Self-reported past admission to the Intensive Care Unit (ICU) with life-threatening asthma (patients at highest risk of adverse asthma outcomes).
- •3. Self-reported hospital admission for asthma in the 12 months before potential study entry (patients at highest risk of adverse asthma outcomes).
- •4. Self-reported treatment with oral prednisone in the six weeks before potential study entry, representing recent unstable asthma.
- •5. A home supply of prednisone for use in worsening asthma.
- •6. Self-reported diagnosis of COPD, bronchiectasis or interstitial lung disease.
- •7. Self-reported greater than 20 pack year smoking history, or onset of respiratory symptoms after the age of 40 years in current or ex-smokers with =10 pack year history.
- •8. Self-reported current pregnancy or breast feeding at the time of enrolment or planned pregnancy within the study period.
- •9. Self-reported congestive heart failure, unstable coronary artery disease, atrial fibrillation or other clinically significant cardiac disease.
- •10. Unwilling or unable to switch from current asthma treatment regimen.
- •11. Other illness(es) likely to compromise participant safety or impact on the feasibility of results, at the discretion of the investigator.
- •12. Self-report of participation in another research trial involving an investigational product, in the past 12 weeks.
- •13. An on treatment FEV1 =50% of predicted at Visit 1 (predicted values must be calculated using the Global Lung Function Initiative equations).
- •14. Any known or suspected contraindications to the Investigational Medicinal Products or excipients.
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