A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma (Phase 2; Protocol No. P04223AM3)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 583
- 主要终点
- Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo
研究概览
简要总结
The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of asthma of at least 6 months duration.
- •Using an Inhaled corticosteroid (ICS), either alone or in combination with a long-acting beta-2 agonist (LABA), for at least 12 weeks prior to the Screening Visit and must have been on a stable asthma regimen for at least 2 weeks prior to the Screening Visit, must not have used oral glucocorticosteroids within 30 days of the Screening Visit.
排除标准
- •Treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalization for management of airway obstruction within 3 months prior to the Screening Visit.
- •History of ventilator support for respiratory failure secondary to asthma.
- •Upper or lower respiratory tract infection (viral or bacterial) within the 2 weeks prior to Screening and Baseline Visits.
- •History of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study or require treatment that might interfere with the study. Specific examples include but are not limited to insulin-dependent diabetes, hypertension, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis. Other conditions that are well controlled and stable will not prohibit participation if deemed appropriate per the investigator's judgment.
- •Inability to correctly use an oral MDI or a DPI.
- •Participation in this study at another investigational site. Participation in a different investigational study at any site during the same time frame of this study.
- •Randomization into this study more than once.
- •Direct association with either the administration of the this study or the study staff.
研究组 & 干预措施
MF MDI 50 mcg BID
Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
干预措施: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg (Drug)
MF MDI 50 mcg BID
Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
干预措施: Placebo Dry Powder Inhaler (DPI) (Drug)
MF MDI 100 mcg BID
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
干预措施: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg (Drug)
MF MDI 100 mcg BID
Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
干预措施: Placebo Dry Powder Inhaler (DPI) (Drug)
MF MDI 200 mcg BID
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
干预措施: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg (Drug)
MF MDI 200 mcg BID
Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
干预措施: Placebo Dry Powder Inhaler (DPI) (Drug)
MF DPI 100 mcg QD
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
干预措施: Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg (Drug)
MF DPI 100 mcg QD
Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
干预措施: Placebo Metered Dose Inhaler (MDI) (Drug)
Placebo
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
干预措施: Placebo Metered Dose Inhaler (MDI) (Drug)
Placebo
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
干预措施: Placebo Dry Powder Inhaler (DPI) (Drug)
结局指标
主要结局
Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo
时间窗: Baseline and Week 12
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.
次要结局
- Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo(Baseline and Week 12)
- Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo(Baseline and Week 12)
- Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD(Baseline and Week 12)