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临床试验/ACTRN12620000721909
ACTRN12620000721909尚未招募2 期

Antioxidant and anti-inflammatory effects of resveratrol in adults with bronchiectasis

Health Research Council of New Zealand0 个研究点目标入组 40 人开始时间: 2020年7月3日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
40

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

  • Aged 18 years or over
  • Able to provide written informed consent
  • Able to provide spontaneous sputum sample at visit 2 (week 0)
  • High-resolution CT (HRCT) chest scan confirming bronchiectasis within the last 5 years
  • Clinically stable during baseline period, for 4 weeks before treatment commencement (defined as absence of clinical worsening beyond normal daily variation, with no need for increasing habitual medications or taking antibiotics or prednisone and stable spirometry)
  • History of at least 1 pulmonary exacerbation requiring antibiotics in the past 12 months
  • Patients with asthma and/or COPD will be included if the primary diagnosis is bronchiectasis

排除标准

  • Oral, intravenous or inhaled antibiotics within 4 weeks prior to commencing study
  • Patients taking continuous macrolide therapy (for 3 months or longer) within 3 months of screening
  • Patients taking continuous oral corticosteroids (for 6 weeks or longer) or immunosuppressive agents (e.g. azathioprine, methotrexate, cyclophosphamide)
  • Bronchiectasis exacerbation / respiratory infection requiring oral or intravenous antibiotic treatment within 4 weeks prior to commencing study treatment
  • Use of prescribed or dietary antioxidant supplement within 1 month of screening
  • Body mass index <18.5 kg/m2
  • Patients with a history of non-compliance with medications
  • Patients with significant medical conditions other than bronchiectasis:
  • Patients with cystic fibrosis
  • Patients with primary ciliary dyskinesia
  • Patients with hypogammaglobulinaemia or other primary or acquired immunodeficiency
  • Patients with allergic bronchopulmonary aspergillosis
  • Pregnant or lactating women
  • Participation in a separate clinical or device trial within 4 weeks of screening
  • Allergy to any components of Transmax
  • Patients with evidence of active or suspected cancer

研究者

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