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临床试验/EUCTR2019-003036-23-GB
EUCTR2019-003036-23-GB进行中(未招募)1 期

Mechanisms of adverse effects of long-acting beta-agonists in asthma - Adverse effects of long-acting beta-agonists in asthma (MAELABA) V5.0

Imperial College London0 个研究点目标入组 24 人开始时间: 2019年10月3日最近更新:
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
24

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

性别
All

入选标准

  • 1) Aged 18 years and above
  • 2) A doctor’s diagnosis of asthma (mild in severity)
  • 3) No current regular asthma treatment or regular asthma treatment in the preceding 6 weeks; only a history of using short-acting bronchodilator inhalers on demand is allowed
  • 4) Pre-bronchodilator FEV1 value greater than or equal to 80% of the predicted value
  • 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 24
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • 1) History or evidence of chronic respiratory disease other than asthma
  • 2) History or evidence of other disease, blood test results outside the normal reference range or medication use that would impair the ability of participants to safely undertake the study or the ability of researchers to interpret the study results; this includes, but is not limited to, the use of anticoagulants (e.g. warfarin), adenosine diphosphate (ADP) receptor inhibitors (e.g. clopidogrel), antiretroviral therapy (due to the potential for interaction with fluticasone), certain antifungal agents (due to the potential for interaction with fluticasone) and beta-blockers
  • 3) Current use or use in the last 6 weeks of systemic or nasal topical steroids, inhaled corticosteroids or systemic immunosuppressants
  • 4) Platelet count < 150 x 109/L or international normalised ratio (INR) > 1.5
  • 5) History of smoking > 5 pack years, current smoker or history of smoking in the last 4 weeks
  • 6) Current vaping or history of vaping in the last 4 weeks
  • 7) Current illicit drug use/abuse
  • 8) Abnormal chest x-ray appearance
  • 9) Signs or symptoms of upper respiratory tract infection or lower respiratory tract infection in the preceding 6 weeks
  • 10) Cardiac conduction abnormalities on electrocardiogram (ECG)
  • 11) Current pregnancy or planning to become pregnant during the study period
  • 12) Breastfeeding during the study period
  • 13) Inability to provide informed consent to participate in the study
  • 14) Current involvement in any other clinical research studies involving medicinal products or devices; or involvement in clinical research studies involving medicinal products within 5 half-lives of the medicinal product
  • 15) Inability to speak English or inability to understand verbal or written English
  • 16) Inability to attend hospital for all scheduled study visits
  • 17) Hypersensitivity to any of the investigational medicinal products (IMPs) or their excipients

研究者

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