A Randomized, Double-blind, Double Dummy Crossover Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma in Patients With Persistent Asthma
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide
研究概览
简要总结
The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.
The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.
详细描述
The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.
The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.
40 subjects will be randomized to receive both active medications in separate testing periods to determine the effect on their lung function after exercise testing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female Patients aged 12 to 50 years with a diagnosis of asthma for at least 6 months before screening
- •Baseline FEV1 of 60% to >100% of predicted
- •Demonstrate a decrease in FEV1 of 15% or greater from baseline after standardized stepped exercise challenge testing
- •Taking a constant dose of low-medium dose inhaled steroids for at least 30 days before screening of either:
- •fluticasone, 88 - 440 mcg/d via MDI or 100 to 500 mcg/d via DPI
- •beclomethasone HFA 80 to 480 mcg/day
- •budesonide DPI 180 to 1200 mcg/ d
- •flunisolide 500 to 2000 mcg/d
- •flunisolide HFA 320 to 640 mcg/d
- •mometasone 200 to 800 mcg/d
- •triamcinolone acetonide 300 to 1500 mcg/ d
排除标准
- •Patients already on LABAs, systemic corticosteroids, or other combination inhaled steroids/LABA medications.
- •Patients not able to safely complete an exercise challenge due to physical constraints outside of their respiratory status.
- •Patients who are pregnant or plan to become pregnant during the study period.
- •Patients with a history of hypersensitivity reaction to either formoterol or budesonide.
- •Patients with any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
- •Patients with planned hospitalization during the study
- •Current Smokers or those with a history of 10 pack years of tobacco use or more.
研究组 & 干预措施
Budesonide/Formoterol first
This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide and dummy inhaler.
干预措施: Budesonide/Formoterol (Drug)
Budesonide/Formoterol first
This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide and dummy inhaler.
干预措施: Budesonide (Drug)
Budesonide first
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide/formoterol and dummy inhaler.
干预措施: Budesonide/Formoterol (Drug)
Budesonide first
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide/formoterol and dummy inhaler.
干预措施: Budesonide (Drug)
结局指标
主要结局
Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide
时间窗: 8 weeks
Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows: (max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))
次要结局
未报告次要终点
研究者
Wanda Phipatanakul
Study PI
Boston Children's Hospital