ACTRN12622000232730尚未招募4 期
A 18-week, randomised, controlled, open-label, parallel-group study in adults with mild asthma, evaluating the efficacy and safety of Arnuity® (fluticasone furoate) Ellipta® 100mcg once daily plus Ventolin® (salbutamol) 100mcg as needed and Flixotide® (fluticasone propionate) Junior Accuhaler® (FP) 100mcg twice daily plus Ventolin® (salbutamol) 100mcg as needed compared with Symbicort® (budesonide/formoterol) Turbuhaler® 200/6mcg as needed.
Dr John D Brannan0 个研究点目标入组 135 人开始时间: 2022年2月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 135
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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •· Provision of informed consent
- •· Adults 18 years of age or older
- •· Physician diagnosis of asthma as mild disease as per GINA 2021 classification
- •· Symptomatic ACQ5 greater than 0.75
- •· Pre-bronchodilator FEV1 more than 80% of predicted
- •· AHR to mannitol at screening with a PD15 to mannitol of less than or equal to 155mg
- •· No ICS use for 1 month prior
- •· Willing and able to give informed consent for participation in the trial
- •· In the Investigator’s opinion, able and willing to comply with all trial requirements
排除标准
- •· Participation in another clinical study
- •· Any asthma worsening requiring change in asthma treatment other than SABA within 30 days prior to Visit 1
- •· Use of oral, rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
- •· Use of leukotriene receptor antagonists within 30 days prior to Visit 1
- •· Known or suspected hypersensitivity to study drugs or excipient
- •· Smoker (current or previous) with a smoking history of less than or equal to 10 pack years
- •· Use of any ß-blocking agent including eye-drops
- •· Medical history of life-threatening asthma including intubation and intensive care unit admission
- •· Hospital admission for asthma in the 12 months prior to Visit 1
- •· Other significant respiratory disease (COPD, bronchiectasis, lung cancer…)
- •· Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study
- •· Planned hospital stay
- •· Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- •· Unwilling or unable to switch from current asthma treatment regimen
- •· Not ready to comply with required medication withholding times for Mannitol challenge testing
- •For randomisation at Visit 3, patients should not fulfil any of the following criteria:
- •· Use of 6 or more SABA ‘as needed’ inhalations per day for at least 4 days of run-in
- •· Any asthma worsening requiring change in asthma treatment other than inhaled SABA from Visit 1 until Visit 3 and/or requiring any asthma treatment other than run-in study medication from Visit 2 until randomisation
研究者
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