ACTRN12620000935932已完成4 期
Treatable traits algortihm guided management of adults with asthma: a feasibility study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years(—)
- 性别
- All
入选标准
- •1) Participant is willing and able to give informed consent for participation in the trial.
- •2) Aged 18 to 75 years on day of enrolment.
- •3) Self-report of a doctor’s diagnosis of asthma.
- •4) Asthma not well-controlled, as measured by an ACQ score greater than or equal to 1.
- •5) Severe asthma exacerbation within the previous year (defined as a presentation to a general practice, after-hours clinic or emergency department resulting in a prescription for oral corticosteroids or treatment with spacer-delivered or nebulised bronchodilator or self-administration of prednisone for asthma for at least 3 days.)
- •6) Receiving treatment with an inhaled corticosteroid containing medication for at least 3 months
- •7) In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •8) Willing to allow his or her General Practitioner and consultant, where relevant, to be notified of participation in the trial.
排除标准
- •1) Inhaled corticosteroid dose >1000mcg fluticasone propionate (FP)/day or equivalent.
- •2) Maintenance oral corticosteroid use for any indication(regular hydrocortisone or fludrocortisone are permitted).
- •3) Oral corticosteroid use within the previous 4 weeks for any indication (regular hydrocortisone or fludrocortisone are permitted).
- •4) Under the care of a severe asthma clinic
- •5)Anti-IgE or anti-IL5 biologics within the previous 4 weeks
- •6) Current immune suppression or immunodeficiency
- •7) Previous ICU admission due to asthma
- •8) Participant who is pregnant, lactating, or planning pregnancy during the course of the trial.
- •9) Serious co-morbidity liable to affect ability to perform study procedures or interpretation of study results, e.g. recent pneumothorax, interstitial lung disease, bronchiectasis, severe heart failure, myocardial infarction within the last 3 months.
- •10) Any other significant disease or disorder (including known contraindication to any of the IMPs or excipients) that, in the opinion of the Investigator, may put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
- •11) Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
研究者
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