Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Time to First Asthma Exacerbation
研究概览
简要总结
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
详细描述
The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat children who have mild asthma.
The study enrolled 240 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
- Ciclesonide 100 µg
- Ciclesonide 200 µg
- Placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the study drug but has no active ingredient.
All participants were asked to take two puffs from a metered-dose inhaler once daily, in the evening, for up to 12 months.
This multi-center trial was conducted in Canada, Hungary and South Africa. The overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks. Participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment.
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
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Symptoms consistent with the diagnosis of asthma for at least 12 months
- •Forced Expiratory Volume in one Second (FEV) at least 80% of predicted
- •Participants who have a history of reversible airway obstruction
- •Good health with the exception of asthma
排除标准
- •History of life-threatening asthma
- •A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- •Participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema)
- •Prematurely born children (<36 weeks of gestation)
- •Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Ciclesonide 200 µg
Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
干预措施: Ciclesonide (Drug)
Ciclesonide 100 µg
Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
干预措施: Ciclesonide (Drug)
结局指标
主要结局
Time to First Asthma Exacerbation
时间窗: Up to 12 months
Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug.
Exacerbations (Post-hoc Analysis of Annual Rates)
时间窗: Up to 12 months
A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age \[years\] and race were identified to be important beside treatment. The parameters centre and age \[years\] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.
次要结局
- Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)(Baseline and Months 1, 2, 4, 6, 8, 10 and 12)
- Growth Velocity as Assessed by Stadiometric Height Measurement(Up to 12 months)
- Mean Rate of Asthma Exacerbations Per Year(Up to 12 months)
- Duration of Exacerbations(Up to 12 months)
- Number of Exacerbations Per Participant(Up to 12 months)
- Percentage of Participants Who Dropped-out Due to Asthma Exacerbation(Up to 12 months)
- Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)(Baseline and Months 1, 2, 4, 6, 8, 10 and 12)
- Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries(Months 1, 2, 4, 6, 8, 10 and 12)
- Change From Baseline in PEF by Diary Entries(Baseline and Months 1, 2, 4, 6, 8, 10 and 12)
- Change From Baseline in Diurnal PEF Fluctuation(Baseline and Months 1, 2, 4, 6, 8, 10 and 12)
- Total Asthma Symptom Score by Diary Entries(Months 1, 2, 4, 6, 8, 10 and 12)
- Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms(Months 1, 2, 4, 6, 8, 10 and 12)
- Rescue Medication Use Per Day(Months 1, 2, 4, 6, 8, 10 and 12)
- Percentage of Rescue Medication Free Days(Months 1, 2, 4, 6, 8, 10 and 12)
- Percentage of Asthma Symptom Free Days(Months 1, 2, 4, 6, 8, 10 and 12)
- Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])(Months 2, 6 and 12)
- Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)(Months 2, 6 and 12)
- Number of Participants With Clinically Significant Vital Signs Findings(Up to 12 months)
- Number of Participants With Clinically Significant Physical Examination Findings(Up to 12 months)
- Number of Participants With Clinically Significant Laboratory Values(Up to 12 months)
- Number of Participants With Adverse Events and Serious Adverse Events(Up to 12 months)