ACTRN12610000916044已完成2 期
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Single-Season Study to Assess the Efficacy and Safety of HI-164OV, an Enteric-coated Oral Vaccine Tablet Containing 45 mg HI-164 Active Substance (Inactivated, Whole Cells of Non-typeable Haemophilus influenzae, isolate 164) for Reducing the Rate and Severity of Acute Exacerbations in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
Hunter Immunology Limited0 个研究点目标入组 340 人开始时间: 2010年10月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 340
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
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. 40 to 85 years of age.
- •2. History of 1 moderate or severe acute COPD exacerbation in the previous 12 months
- •3. An established diagnosis of COPD and severity status of moderate to severe defined by a post bronchodilator FEV1 <60% of predicted value and post-bronchodilator FEV1/FVC < 0.7.
- •4. Willingness and ability to give signed informed consent.
排除标准
- •1. Planned or previous lung transplantation, lung volume reduction surgery, or other lung surgery for emphysema.
- •2. A primary diagnosis of bronchiectasis.
- •3. Current respiratory disorders other than COPD (e.g., lung cancer, sarcoidosis, tuberculosis, restrictive lung disease/benign tumours).
- •4. History of asthma as primary diagnosis as an adult.
- •5. Unresolved acute COPD exacerbation.
- •6. 6.Oral/parenteral corticosteroids in excess of 10 mg/day, or antibiotics taken for all acute conditions (including acute exacerbations of COPD), within four weeks of the scheduled first dose of study medication. This does not apply to background antibiotic maintenance therapy.
- •7. New therapy or a change in dose of existing therapy for COPD, including, but not limited to, inhaled bronchodilators and inhaled corticosteroids, started within 4 weeks prior to the first dose of study medication.
- •8. Participation in a clinical trial of any other vaccine, drug, or immune stimulating agent within three months of screening and for the duration of the study.
- •9. History of systemic immunosuppressive therapy (including systemic corticosteroids at an equivalent prednisone dose of >10 mg/day) within 4 weeks prior to randomisation.
- •10. Women who are pregnant, breast-feeding, or of child-bearing potential without effective contraception.
- •11. Any significant medical disorder which would preclude evaluation of the participant's condition. Participants with impaired hepatic function defined as raised liver function tests greater than 2.5 times upper limit of normal range.
- •13. Participants with impaired renal function defined as serum creatinine > 177 umol/L.
- •13. Cancer within the previous five years (except for non-melanomatous skin cancer and non-invasive cervical cancer).
- •14. Life expectancy of less than 1 year.
- •15. Participants with lactose intolerance.
- •16. Any other medical or social reason the Investigator feels justifies exclusion of the participant, including being likely to withdraw, not comply or be able to understand the protocol requirements.
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