Childhood Asthma Management Program
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,041
- 主要终点
- Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period
研究概览
简要总结
The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
详细描述
BACKGROUND:
Asthma is a serious chronic condition, affecting approximately 14 million Americans. People with asthma experience well over 100 million days of restricted activity annually, and costs for asthma care exceed $10 billion a year. Asthma is much more prevalent among children than adults.
Hospitalizations for asthma have been increasing among children. For example, from 1979 to 1987, the hospital discharge rate with asthma as the first-listed diagnosis rose 43 percent among children less than 15 years of age, from 19.8 to 28.4 discharges per 10,000 population.
Death rates for asthma are greater in Blacks than in whites, and the difference is increasing. In 1979, Blacks of both sexes were about twice as likely to die from asthma as whites. Over the past decade this ratio has increased, and by 1987 the asthma death rate was almost three times greater among Blacks than whites. In children, these mortality differences between Blacks and whites are even more striking.
Current knowledge about the epidemiology and natural history of childhood asthma is incomplete, but the relationship between asthma early in life and development of chronic obstructive pulmonary disease (COPD) in adulthood is becoming more apparent. Asthmatic children with persistent and severe asthma symptoms have lower levels of lung function by young adulthood than those with milder disease. Recent longitudinal studies have confirmed a decrease in rate of growth of lung function as measured by FEV1 among symptomatic (primarily wheeze) children compared to asymptomatic children. Among persons who develop COPD, initial level of lung function is the strongest predictor of subsequent rapid decline of ventilatory function.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1 Budesonide
Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
干预措施: Budesonide (Drug)
2 Nedocromil
Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
干预措施: Nedocromil (Drug)
3 Placebo
Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
干预措施: Placebo (Drug)
结局指标
主要结局
Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period
时间窗: At the end of treatment, 4-6 years from baseline assessment
Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). Percent predicted determined from three separate published sets of reference equations for white, black, and Hispanic children - see NEJM 343: 1054-1062, 2000 for more details and references.
次要结局
- Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs(4-6 years from baseline)
- Change From Baseline in the Rate of Asthma Free Days(4-6 years from baseline)
- Need for Urgent Care for Asthma(4-6 years from baseline)
- Mortality(4-6 years from baseline)
- Change in Height From Baseline to End of Treatment, 4-6 Years Later(4-6 years from baseline)
- Standardized Depression Scale -- Children's Depression Inventory(4-6 years from baseline)
研究者
James Tonascia
Principal Investigator, CAMP Data Coordinating Center
Johns Hopkins Bloomberg School of Public Health
