ACTRN12620000721909尚未招募2 期
Antioxidant and anti-inflammatory effects of resveratrol in adults with bronchiectasis
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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