ISRCTN16755478已完成不适用
Experimental Human Pneumococcal Carriage Model (Programme Grant):The effect of asthma on immune response to pneumococcus
iverpool School of Tropical Medicine0 个研究点目标入组 62 人开始时间: 2016年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. World Health Organisation performance status 0 (able to carry out all normal activity without restriction) or 1 (restricted in strenuous activity but ambulatory and able to carry out light work)
- •2. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
- •3. Access to their own mobile telephone (safety and timely communication)
- •4. Capacity to give informed consent
- •5. Adults aged 18-50 years, with a physician diagnosis of asthma; BTS treatment step 2 and 3 (see Appendix 1)
- •6. No exacerbations requiring antibiotics or oral steroids within the last 28 days
- •7. Spirometry: Forced Expiratory Volume in one second >70% predicted
排除标准
- •1. Close physical contact with at-risk individuals (children under 5yrs, immunosuppressed adults) - minimise risk of pneumococcal transmission
- •2. History of drug or alcohol abuse (frequently drinking over the recommended alcohol intake limit: men and women should not regularly drink more than 14 units of alcohol per week. – minimise risk of pneumococcal disease
- •3. Smoking any cigarettes currently or within the last six months - minimise risk of pneumococcal disease
- •4. Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease (For loose tobacco: ounces per week × 2/7 × number of years smoked ?=? pack years(22))
- •5. Taking regular daily medications that may affect the immune system e.g. oral steroids, steroid nasal spray, antibiotics, and disease-modifying anti-rheumatoid drugs.
- •6. Any acute illness (new symptoms within preceding 14 days which are unexplained by the known past medical history)
- •7. Having received any antibiotics, oral steroids or nasal steroid spray in the preceding 28 days
- •8. More than 1 asthma exacerbation in the last twelve months (Asthma exacerbation defined as an acute episode of progressive worsening of symptoms of asthma, including shortness of breath, wheezing, cough, and chest tightness, or a decline in objective measure such as peak expiratory flow rates of more than 30 percent requiring treatment with oral corticosteroids for a period of 3 days or more)
- •9. Taking medication that affects blood clotting e.g. aspirin, clopidogrel, warfarin or other oral or injectable anticoagulants
- •10. History of culture-proven pneumococcal disease
- •11. Allergy to penicillin/amoxicillin
- •12. Currently involved in another clinical trial unless observational or in follow-up (non-interventional) phase.
- •13. Have been involved in a clinical trial involving EHPC and bacterial inoculation in the past three years
- •14. Significant cardiorespiratory disease (excluding stable hypertension, and asthma at treatment step 2 and 3)
- •15. Disease associated with altered immunity, including diabetes, alcohol abuse, malignancy, rheumatological conditions
- •16. Pregnancy
- •17. Taking any medications except those on the allowed list”. The allowed medications” list encompasses mediations which will not cause significant alteration to our measures of immune function, and which are used in the treatment of co-morbidities. These are: statins; anti hypertensives in stable hypertension; antidepressants; bisphosphonates; treatment for benign prostatic hyperplasia; hormone replacement therapy; vitamin supplements (including multivitamins, iron); anti-acid medications; nicotine replacement therapy (NRT), inhaled steroids upto 800 micrograms BDP equivalent per day, inhaled beta 2 agonists and leukotriene receptor antagonist.
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