ISRCTN99085436进行中（未招募）3 期
The efficacy and mechanisms of action of n-3 poly-unsaturated fatty acid supplementation in people with non-steroidal exacerbated airways disease and uncontrolled asthma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 98
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. Aged =18 years. N-ERD does not occur at birth and it rarely occurs in children
- •2. Diagnosis of N-ERD according to one of:
- •2.1. Positive aspirin challenge plus history of nasal polyposis or asthma
- •2.2. More than one typical reaction to NSAIDs or aspirin plus history of nasal polyposis or asthma
- •2.3. A single typical reaction to NSAIDs or aspirin and a history of nasal polyposis plus moderate to severe asthma*
- •2.4. History of nasal polyposis plus asthma plus blood eosinophilia (=300 x 10e6/l) or raised FENO (>25 ppb) within last 12 months plus urinary leukotriene E4/creatinine >800 pg/mg
- •3. ACQ of more than 1.5 as this indicates poor control. This is required to ensure there is a clinical need or a requirement to alter medication
- •4. Stable disease, as evidenced by a lack of change in asthma therapy within the last 6 weeks
- •*Defined as asthma requiring at least low dose inhaled corticosteroid plus long acting bronchodilator or resulting in at least two asthma attacks per year
排除标准
- •1. Tolerant to aspirin or NSAID with no respiratory or nasal reaction on exposure
- •2. Significant cardiac disease, respiratory disease or other cause for breathlessness which, according to the principal investigator, contributes to the patient’s symptoms of breathlessness or other respiratory symptoms to a greater degree than the patient’s asthma
- •3. Severe or uncontrolled co-morbid disease (other than nasal polyps) which is likely to affect the outcome of the study
- •4. Having had an upper or lower respiratory tract infection requiring antibiotics within four weeks of randomisation
- •5. Receiving biologic agents
- •6. Receiving n-3 fatty acid oral supplements or more than two dietary portions of oily fish per week
- •7. Current smoker or more than 15 pack-year smoking history
- •8. Consumption of more than 21 units of alcohol per week as alcohol-induced respiratory symptoms are more common in N-ERD.
- •9. Pregnant or breastfeeding women and those less than 4 weeks postpartum
- •10. Women of child bearing potential (WOCBP) not using a highly effective form of contraceptive. Pregnancy tests will be required at trial start and at 12 weeks. Highly effective forms of contraception defined as: Methods of birth control which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such, as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner. This will apply to all women under 55 years of age unless they are postmenopausal or sterile. Postmenopausal is defined as at least 12 months of spontaneous amenorrhea or 24 weeks of spontaneous amenorrhoea with serum FSH >40 mIU/ml. Surgically sterile is defined as females who have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to enrolment.
- •11. Participation in the active phase of another CTIMP or within 4 weeks (or the half life of the drug if longer) of last study drug administration. Participation in observatory trials can occur if agreed between the PI of each trial and where this does not impact the patient or the outcomes of either trial
- •12. Patients unable to give written informed consent
研究者
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