Use of Pathological Phenotype to Determine Optimal Management for Moderate to Severe Preschool Wheeze
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Unscheduled Healthcare Visits (UHCV)
研究概览
简要总结
This is a single-centre, randomised-controlled trial, comparing management of preschool wheeze. It specifically aims to compare management of preschool wheeze using current clinical guidelines to management determined by eosinophilic inflammation and infection. Participants will be children aged 1-5 years who have recurrent wheezing and will be allocated to one of two treatment groups, either current clinical care or pathological phenotype based management. They will be asked to make 2 study visits to the Royal Brompton Hospital over the course of 4 months.
详细描述
This study will determine the efficacy of treating preschool wheeze based on objective biomarkers of inflammation and presence of bacterial infection, and compare this to current clinical guidelines based management. Subjects will be recruited from out-patient clinics and attend for a screening/research visit during which assessments of pathological phenotype (bacterial infection and inflammation) will be made from induced sputum and blood. Their clinical phenotype will be determined by the Consultant. Subsequently, patients will be randomised to one of two arms:
i) current clinical care ( as directed by their Consultant) ii) pathological phenotype based management- presence of eosinophilia in blood (_> 2%) or induced sputum (>2.4%) - will receive twice daily inhaled steroids ( beclometasone 200mcg bd) for 4 months, presence of bacterial infection in induced sputum or oropharyngeal swab- will receive 4 weeks of antibiotics targeted to the isolate, IF BOTH eosinophilic inflammation AND infection are present, then inflammation alone will be treated for 4 months.
All patients will continue on as required bronchodilator therapy, and any other anti-inflammatory therapy ( other than inhaled steroids) e.g. montelukast.
All participants will undergo an initial research/screening visit which will involve the following tests:
Full blood count Total serum immunoglobulin E and radioallergosorbent test to house dust mite, grass pollen, tree pollen, cat, dog, aspergillus, milk, egg, peanut Assessment of lung function by incentive spirometry and lung clearance index (LCI) using the multiple breath washout technique Exhaled nitric oxide- using the offline tidal breathing technique Sputum induction using nebulised hypertonic saline Oro- pharyngeal swab Symptom questionnaire Health related quality of life questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reported recurrent wheeze, needing at least 2 courses of oral steroids in the last 12 months, at least one course of oral steroids in the last 6 months
- •Past wheeze confirmed by a clinician
排除标准
- •Any known cardiac disease
- •Any chronic respiratory condition (other than preschool wheeze) diagnosed by a physician
- •Any chronic condition that increases susceptibility to respiratory tract infections such as severe developmental delay and feeding difficulty/unsafe swallow Prematurity <34 weeks, or requirement of ventilation in the newborn period History of neonatal chronic lung disease Family not contactable by telephone
研究组 & 干预措施
Pathological phenotype
Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
干预措施: Beclometasone (Drug)
Pathological phenotype
Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
干预措施: Co-amoxiclav (Drug)
Pathological phenotype
Regular inhaled steroids- Beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co- amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
干预措施: Azithromycin (Drug)
Clinical guidelines
The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
干预措施: Beclometasone (Drug)
Clinical guidelines
The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
干预措施: Co-amoxiclav (Drug)
Clinical guidelines
The children will be treated as directed by their Consultant Paediatrician. The treatment may include- regular inhaled steroids- beclometasone dipropionate 200mcg bd for 4 months OR antibiotic therapy- Co-amoxiclav (0.3ml/kg bd) or Azithromycin (10mg/kg od) for 4 weeks
干预措施: Azithromycin (Drug)
结局指标
主要结局
Number of Unscheduled Healthcare Visits (UHCV)
时间窗: 4 months
Actual number of unscheduled healthcare visits (UHCV) includes GP, A\&E or hospital admission. This is median number of visits in 4 months - with range.
次要结局
- Number of Courses of Oral Steroids(4 months and up to 1 year later)
- Health Related Quality of Life(4 months)
- Symptom Days(4 months)