Effect of Extra- Fine Versus Coarse-Particle Inhaled Corticosteroids (ICS) on Ventilation Heterogeneity in Children With Poorly Controlled Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Ventilation Heterogeneity Index (VHI)
研究概览
简要总结
The primary objective of the study is to show that ventilation heterogeneity identified by hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or not eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry powder).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls between the ages of 6 and 17 years
- •Diagnosis of asthma based on NAEPP3 criteria
- •Poor asthma control based on one or more of the following criteria:
- •an ACT ≤ 19 and/or ACQ ≥ 1.5 units at the screening and/or randomization visits despite continuous or intermittent treatment with ICS and/or an anti-leukotriene within six months before enrollment.
- •Any airflow obstruction based on Hankinson et al reference standards: FEV1 % < 80% predicted, an FEV1/FVC ratio < 90% predicted, and/or an FEF 25-75 < 70% predicted at the screening and/or randomization visits.
- •Frequent severe exacerbations as reflected by ≥ 2 bursts of systemic corticosteroids (≥ 3 days each) in the previous 12 months.
- •Serious exacerbations reflected by at least one hospitalization, ICU stay, or mechanical ventilation in the previous 12 months
- •"Not well controlled" by NAEPP or GINA asthma treatment guidelines
- •For post-pubertal females, negative urine pregnancy screen and willing if sexually active (as counseled by a female study coordinator in private) to using a consistent and appropriate method of birth control for the duration of the study.
排除标准
- •Premature birth < 35 weeks estimated gestational age
- •Maintenance oral prednisone (defined as daily or alternate day for the past three months before screening) or omalizumab treatment for asthma control
- •Any significant medical condition that might inform maldistribution of ventilation apart from asthma including bronchiectasis, cardiac disease, congenital anomalies of the respiratory system, neurodevelopmental delay with cognitive impairment, ciliary dyskinesia syndromes, immune deficiency, recent lower respiratory infection (within six weeks of screen visit). Co-morbidities associated with asthma including sleep apnea syndrome, obesity, GERD, and right middle lobe syndrome are not criteria for exclusion.
- •Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in the eye, pacemaker, or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
- •Chest circumference greater than that of the helium coil. The circumference of the coil is approximately 42 inches.
- •Inability to understand simple instructions or to hold still for 10 seconds.
研究组 & 干预措施
Beclomethasone
Subjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks)
干预措施: beclomethasone (Drug)
fluticasone
Subjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks)
干预措施: fluticasone (Drug)
结局指标
主要结局
Ventilation Heterogeneity Index (VHI)
时间窗: Baseline
VHI = lung defect volume divided by total lung volume. It is a ratio scale.
次要结局
- Change in Ventilation Heterogenity Index (VHI)(Baseline (week 0), week 12, week 16, and week 24)
研究者
Willliam Gerald Teague
Chief, Division of Respiratory Medicine, Allergy, and Immunology
University of Virginia