A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate/Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Children With Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 181
- 主要终点
- Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60
研究概览
简要总结
This study compares the 12-week efficacy and 24-week safety of mometasone furoate/formoterol fumarate (MF/F) 100/10 mcg and mometasone furate (MF) 100 mcg, both administered twice daily (BID) via metered-dose inhaler (MDI) in children aged 5 to 11 years with persistent asthma.
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)
盲法说明
1:1 randomization to double-blinded MF/F MDI 100/10 mcg BID and MF MDI 100 mcg BID
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
- •Has a diagnosis of asthma of ≥ 6-months duration according to the Global Initiative for Asthma (GINA) guidelines
- •Has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA) ≥ 4 weeks
- •Is able to demonstrate an FEV1 >60% and ≤90% predicted
- •Is able to demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of albuterol/salbutamol.
- •Is able to use an MDI (without spacer), use a peak flow meter, and perform spirometry correctly.
- •Is willing (with consent of their parent(s)/guardian) to discontinue previously prescribed asthma medication, if there is no inherent harm in changing the participant's current asthma therapy.
- •Has laboratory tests that are clinically acceptable to the investigator.
排除标准
- •Requires >8 inhalations per day of albuterol (100 mcg per actuation), and/or >2 nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days
- •Has a clinical worsening of asthma that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) between the Screening and Baseline visits.
- •Is considered by the investigator to have unstable asthma at the end of the run-in period
- •Has had > 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and/or ≥ 24-hour stay in an emergency department, urgent care center, or hospital) within 1 year prior to visit 1
- •Has had a history of life-threatening asthma
- •Has a clinically significant condition or situation, other than the condition being studied which may interfere with trial evaluations, participant safety, or optimal participation in the trial
研究组 & 干预措施
MF/F MDI 100/10 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks.
干预措施: MF/F MDI 100/10 mcg BID (Drug)
MF MDI 100 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks.
干预措施: MF MDI 100 mcg BID (Drug)
MF/F MDI 100/10 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks.
干预措施: MF MDI 100 mcg BID (Open Label) (Drug)
MF/F MDI 100/10 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks.
干预措施: Albuterol/Salbutamol PRN (Drug)
MF/F MDI 100/10 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks.
干预措施: Prednisone/Prednisolone (Drug)
MF MDI 100 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks.
干预措施: MF MDI 100 mcg BID (Open Label) (Drug)
MF MDI 100 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks.
干预措施: Albuterol/Salbutamol PRN (Drug)
MF MDI 100 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks.
干预措施: Prednisone/Prednisolone (Drug)
结局指标
主要结局
Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60
时间窗: Baseline, and average of Day 1, Weeks 1, 4, 8, and 12
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 60 minutes post-dose (at 0, 5, 15, 30 and 60 minutes) and averaged across study visits in the Treatment Period (Day 1, Week 1, Week 4, Week 8 and Week 12) compared to Baseline. Baseline was the average of % predicted FEV1 values at 30 min and 0 min pre-dose. At each visit, the area under the curve is calculated over the post-dose timepoints. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC.
Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)
时间窗: Up to 26 weeks
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.
Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE
时间窗: Up to 24 weeks
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.
次要结局
- Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment(Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points)
- Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment(Baseline, Day 1 and Week 12)
- Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment(Baseline and Weeks 4, 8, and 12 (Averaged))
- Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment(Baseline and Weeks 1-12 (Averaged))
- Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period(Baseline and Weeks 1-12 (Averaged))
- Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period(Weeks 1-12 (Averaged))
- Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12)(Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12)
- Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last)(Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12)
- Maximum Plasma Concentration (Cmax) of Mometsone Furoate(Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12)
- Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate(Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12)