A Randomized, Evaluator-Blind, Crossover, Single Dose Study of the Bronchodilator Effect of Formoterol Fumarate in Combination With Mometasone Furoate Metered Dose Inhaler Delivered With and Without a Spacer Versus Placebo and Foradil® Aerolizer® in Children With Persistent Asthma (Protocol No. P06476)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer
研究概览
简要总结
A study to compare the bronchodilatory effect of a single dose of Mometasone Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder inhaler (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each participant was to receive a single dose of each of 4 treatments in each period. Each treatment period was separated by a 5 to 7 day washout period. It assumed that a single dose MF/F MDI 100/10 microgram (mcg) delivered with a spacer would produce bronchodilation, defined as a significant increase in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours (AUC[0-12 hr]) when compared to placebo.
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 (Investigator)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of asthma of at least 6 months duration
- •Must have taken an Inhaled Corticosteroid ([ICS]; alone or in combination with a long-acting beta-2 Agonist [LABA]) for at least 3 months prior to the Screening Visit and must have been on a stable daily dose for at least 2 weeks prior to the Screening Visit
- •FEV1 must be at least 70% predicted after all restricted medications have been withheld for the appropriate intervals
- •Must demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of 360 mcg albuterol (4 inhalations x 90 mcg, ex-actuator) or of nebulized albuterol (2.5 mg), if confirmed as standard office practice
排除标准
- •Has been treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalized for management of airway obstruction within 3 months prior to the Screening Visit
- •Has required ventilator support for respiratory failure secondary to asthma
- •Demonstrates a decrease in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit
- •Requires the use of greater than 8 inhalations per day of short-acting beta-2 agonists (SABA) MDI, or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit
- •Experiences a clinical deterioration in asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA) as judged by the investigator, at any time from the Screening Visit up to and including the Baseline Visit
研究组 & 干预措施
Sequence 1
Treatment Period 1: Placebo MDI with spacer; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: F DPI
干预措施: Formoterol Fumarate DPI (Drug)
Sequence 1
Treatment Period 1: Placebo MDI with spacer; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: F DPI
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer (Drug)
Sequence 1
Treatment Period 1: Placebo MDI with spacer; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: F DPI
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer (Drug)
Sequence 1
Treatment Period 1: Placebo MDI with spacer; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: F DPI
干预措施: Placebo MDI with spacer (Drug)
Sequence 1
Treatment Period 1: Placebo MDI with spacer; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: F DPI
干预措施: Mometasone Furoate DPI (Drug)
Sequence 2
Treatment Period 1: F DPI; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI with spacer
干预措施: Formoterol Fumarate DPI (Drug)
Sequence 2
Treatment Period 1: F DPI; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI with spacer
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer (Drug)
Sequence 2
Treatment Period 1: F DPI; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI with spacer
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer (Drug)
Sequence 2
Treatment Period 1: F DPI; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI with spacer
干预措施: Placebo MDI with spacer (Drug)
Sequence 2
Treatment Period 1: F DPI; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI with spacer
干预措施: Mometasone Furoate DPI (Drug)
Sequence 3
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: Placebo MDI with spacer; Treatment Period 4: MF/F MDI with spacer
干预措施: Formoterol Fumarate DPI (Drug)
Sequence 3
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: Placebo MDI with spacer; Treatment Period 4: MF/F MDI with spacer
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer (Drug)
Sequence 3
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: Placebo MDI with spacer; Treatment Period 4: MF/F MDI with spacer
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer (Drug)
Sequence 3
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: Placebo MDI with spacer; Treatment Period 4: MF/F MDI with spacer
干预措施: Placebo MDI with spacer (Drug)
Sequence 3
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: Placebo MDI with spacer; Treatment Period 4: MF/F MDI with spacer
干预措施: Mometasone Furoate DPI (Drug)
Sequence 4
Treatment Period 1: Placebo MDI without spacer; Treatment Period 2: MF/F MDI with spacer; Treatment Period 3: F DPI; Treatment Period 4: MF/F MDI without spacer
干预措施: Formoterol Fumarate DPI (Drug)
Sequence 4
Treatment Period 1: Placebo MDI without spacer; Treatment Period 2: MF/F MDI with spacer; Treatment Period 3: F DPI; Treatment Period 4: MF/F MDI without spacer
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer (Drug)
Sequence 4
Treatment Period 1: Placebo MDI without spacer; Treatment Period 2: MF/F MDI with spacer; Treatment Period 3: F DPI; Treatment Period 4: MF/F MDI without spacer
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer (Drug)
Sequence 4
Treatment Period 1: Placebo MDI without spacer; Treatment Period 2: MF/F MDI with spacer; Treatment Period 3: F DPI; Treatment Period 4: MF/F MDI without spacer
干预措施: Placebo MDI without spacer (Drug)
Sequence 4
Treatment Period 1: Placebo MDI without spacer; Treatment Period 2: MF/F MDI with spacer; Treatment Period 3: F DPI; Treatment Period 4: MF/F MDI without spacer
干预措施: Mometasone Furoate DPI (Drug)
Sequence 5
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI without spacer
干预措施: Formoterol Fumarate DPI (Drug)
Sequence 5
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI without spacer
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer (Drug)
Sequence 5
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI without spacer
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer (Drug)
Sequence 5
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI without spacer
干预措施: Placebo MDI without spacer (Drug)
Sequence 5
Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI without spacer
干预措施: Mometasone Furoate DPI (Drug)
Sequence 6
Treatment Period 1: MF/F MDI with spacer; Treatment Period 2: Placebo MDI without spacer; Treatment Period 3: MF/F MDI without spacer; Treatment Period 4: F DPI
干预措施: Formoterol Fumarate DPI (Drug)
Sequence 6
Treatment Period 1: MF/F MDI with spacer; Treatment Period 2: Placebo MDI without spacer; Treatment Period 3: MF/F MDI without spacer; Treatment Period 4: F DPI
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer (Drug)
Sequence 6
Treatment Period 1: MF/F MDI with spacer; Treatment Period 2: Placebo MDI without spacer; Treatment Period 3: MF/F MDI without spacer; Treatment Period 4: F DPI
干预措施: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer (Drug)
Sequence 6
Treatment Period 1: MF/F MDI with spacer; Treatment Period 2: Placebo MDI without spacer; Treatment Period 3: MF/F MDI without spacer; Treatment Period 4: F DPI
干预措施: Placebo MDI without spacer (Drug)
Sequence 6
Treatment Period 1: MF/F MDI with spacer; Treatment Period 2: Placebo MDI without spacer; Treatment Period 3: MF/F MDI without spacer; Treatment Period 4: F DPI
干预措施: Mometasone Furoate DPI (Drug)
结局指标
主要结局
Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer
时间窗: Up to 12 hours postdose
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.
次要结局
- AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer(Up to 12 hours postdose)
- Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose(Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose)
- AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer(Up to 12 hours postdose)
- AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI(Up to 12 hours postdose)
- AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI(Up to 12 hours postdose)
- AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of F DPI Compared to Placebo MDI Combined With or Without Spacer(Up to 12 hours postdose)
- Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose(Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose)