A Randomized, Cross Over Study Evaluating the Effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on Short Term Growth in Pediatric Subjects With Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
研究概览
简要总结
Children with mild persistent asthma that have asthma symptoms once or twice a week and use a daily controller, while children with mild intermittent asthma rarely have asthma symptoms and do not use a daily controller. Inhaled corticosteroids are the standard treatment for mild peristent asthma. The purpose of this study is to measure children rate of growth while on different inhaled corticosteroids.
详细描述
A randomized, cross over study evaluating the effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on short term growth in pediatric subjects with asthma.
Objectives:
- The primary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus Pulmicort Flexhaler 180 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma.
- The secondary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus QVAR 80 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma.
Aims:
- The primary aim is to show that there is a growth suppressive effect of Pulmicort Flexhaler 180 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.
- The secondary aim to show that there is a growth suppressive effect of QVAR 80 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.
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
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).
- •All subjects must have a history of physician diagnosed mild intermittent or mild persistent asthma as documented by PCP medical record or detailed history by study investigator.
- •All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history.
- •All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination.
- •Subjects may be on current treatment with montelukast as this drug does not affect growth. If a subject is on montelukast at screening/baseline, they will remain on a stable dose throughout the study.
- •Subjects must be willing to comply with study requirements.
排除标准
- •Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines.
- •Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days.
- •Subjects will be excluded if they had more than one burst of systemic steroids within the past year.
- •Subjects will be excluded if their baseline FEV1 is < 80% predicted.
- •Subjects will be excluded if they have any other serious systemic disease other than asthma.
- •Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days
- •Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose.
- •Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles.
- •Subjects will be excluded if they have any history of tuberculosis of the respiratory tract.
- •Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections.
- •Subjects will be excluded if they have any history of herpes simplex infection of the eye.
- •Subjects will be excluded if they have taken any immunosuppressive drugs within the past 2 months.
- •Subjects will be excluded if they have any history of Churg-Strauss syndrome or other eosinophilic disorders.
- •Subjects will be excluded if an investigator deems they have any mental or development health issues, such as autism, moderate to severe mental retardation or severe ADHD,that interferes with their ability to complete the knemometry measurements.
- •Subjects will be excluded if an investigator deems they have any physical issues, such as inability to sit independently or amputation of lower leg, that interferes with their ability to complete the knemometry measurements.
研究组 & 干预措施
1 Treatment Sequence, FPQ
Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR
干预措施: Fluticasone, Budesonide, Beclomethasone (Drug)
2 Treatment Sequence, FQP
Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort
干预措施: Fluticasone, Beclomethasone, Budesonide (Drug)
3 Treatment Sequence, PFQ
Period 2 Pulmicort Period 4 Flovent Period 6 QVAR
干预措施: Budesonide, Fluticasone, Beclomethasone (Drug)
4-Treatment Sequence, PQF
Period 2 Pulmicort Period 4 QVAR Period 6 Flovent
干预措施: Budesonide, Beclomethasone, Fluticasone (Drug)
5 Treatment Sequence, QFP
Period 2 QVAR Period 4 Flovent Period 6 Pulmicort
干预措施: Beclomethasone, Fluticasone, Budesonide (Drug)
6 Treatment Sequence, QPF
Period 2 QVAR Period 4 Pulmicort Period 6 Flovent
干预措施: Beclomethasone, Budesonide, Fluticasone (Drug)
结局指标
主要结局
Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
时间窗: 1 yr
Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
次要结局
- Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID.(1 yr)
研究者
Deborah Gentile
Principal Investigator
West Penn Allegheny Health System