An Open-Label Study to Assess the Safety and Tolerability of Zenhale® (a Fixed-Dose Combination of Mometasone Furoate/Formoterol Fumarate Delivered by Metered Dose Inhaler) in 40 Subjects With Persistent Asthma (Protocol No. 206-00 [P08212])
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Number of Participants With At Least One Serious AE
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability & effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults & adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma of at least 6 months duration
- •Current use of a medium or high daily dose of an inhaled corticosteroid (ICS) (alone or in combination with a long-acting beta agonist [LABA]) for at least 6 weeks prior to Screening AND must be on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening
- •Agrees to change asthma therapy (if changing asthma therapy poses no inherent risk)
- •If female of reproductive potential, agrees to remain abstinent or use 2 acceptable methods of birth control during study participation. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraceptive
排除标准
- •Treatment in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction within previous 3 months
- •Any prior ventilator support for respiratory failure secondary to asthma,
- •Upper or lower respiratory tract infection (viral or bacterial) within previous 2 weeks
- •History of a medical condition that, in the investigator's opinion, may interfere with study participation,
- •History of smoking within previous year or a cumulative smoking history of more than 10 pack-years
- •Known allergy to or intolerance of ICSs, LABAs, or any of the ingredients included in the study medications
- •History of use of illicit drugs
- •Inability to correctly use an oral MDI
- •Pregnant, breastfeeding or plans to become pregnant during study
研究组 & 干预措施
MF/F 200/10 mcg MDI BID
Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks
干预措施: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI (Drug)
MF/F 400/10 mcg MDI BID
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
干预措施: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI (Drug)
结局指标
主要结局
Number of Participants With At Least One Serious AE
时间窗: Up to Week 14
A serious AE was defined as any untoward medical occurrence or effect that at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer.
Number of Participants Who Discontinued From the Study Due to an AE
时间窗: Up to Week 12
An AE was 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, whether or not considered related to this medicinal product.
Number of Participants With At Least One Adverse Event (AE)
时间窗: Up to Week 14
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Number of Participants With At Least One Drug-Related AE
时间窗: Up to Week 14
A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
次要结局
- Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12(Baseline and Week 12)