NCT00835094已完成4 期
A Randomized Trial Assessing the Chronobiology of Once Daily Administration of Mometasone Furoate DPI in Patients With Asthma
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 216
- 主要终点
- To compare the incidence of adverse events of MF-DPI 400 mcg once daily administered in the morning compared to the evening.
研究概览
简要总结
This will be an open-label, randomized, parallel-group comparison of mometasone furoate dry powder inhaler (MF-DPI) 400 mcg once daily administered in the morning vs. the evening for 12 weeks in subjects with 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
- 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
- •Subjects (and their parent/guardian if the subject is <18) must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- •Subjects must be >=12 years of age (unless restricted to an older age by local ethical committees or national health authorities), of either gender and any race.
- •Subjects must have had a history of asthma for >=6 months.
- •If the subject is taking inhaled corticosteroids, the daily dose must be <= the upper limit defined below:
- •budesonide <=800 mcg/day
- •triamcinolone acetonide <=800 mcg/day
- •beclomethasone dipropionate <=1000 mcg/day
- •fluticasone propionate <=500 mcg/day
- •flunisolide <=1000 mcg/day
- •Women of childbearing potential must have a negative urine (hCG) pregnancy test on the day of randomization (Baseline visit).
- •Women of childbearing potential (includes women who are <1 year postmenopausal) must be using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation).
- •Subjects must agree to inform their usual treating physician (if other than the study investigator) of their participation in this study.
排除标准
- •Female subjects who are pregnant, breast-feeding, or are premenarcheal.
- •Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 6 months immediately prior to Visit 1, and/or subjects who have required a course of systemic corticosteroids within the previous month.
- •Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks.
- •Subjects who have been admitted to the hospital for asthma control within the previous 3 months or more than once within the previous 6 months.
- •Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years.
- •Subjects who have used any investigational drug in the 30 days prior to Baseline, or subjects who have been treated with any investigational antibody for asthma in the 90 days prior to Baseline.
- •Subjects who are allergic or have had an idiosyncratic reaction to corticosteroids.
- •Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system, or respiratory disease other than asthma (eg, COPD), or any other disorder which may interfere with the study evaluations or affect subject safety.
- •Subjects with a history of drug abuse, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study.
结局指标
主要结局
To compare the incidence of adverse events of MF-DPI 400 mcg once daily administered in the morning compared to the evening.
时间窗: 12 weeks
Between-treatment group comparisons (MF-DPI 400 mcg once daily in the morning compared to the evening) of daytime and nocturnal symptoms based on a 4 point scale.
时间窗: 12 weeks
次要结局
- To assess morning vs. evening compliance with therapy.(12 weeks)
- To assess subject satisfaction with the Twisthaler^TM device.(12 weeks)
研究者
相似试验
已完成
2 期
Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent AsthmaAsthmaNCT01555151Novartis Pharmaceuticals739
已完成
4 期
A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)Drug Therapy, CombinationNCT02780622Hoffmann-La Roche20
已完成
3 期
A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)AsthmaNCT05202262AstraZeneca645
已完成
1 期
A Comparison of Mometasone Nasal Spray, Nasonex Nasal Spray, Nasonex Nasal Spray Suspension, & Placebo for Treatment of Seasonal Allergies for Safety, Efficacy, & Superiority in 1520 Male & Female VolunteersTreatment of the Signs and Symptoms of Seasonal Allergic RhinitisNCT02109185Mylan Pharmaceuticals Inc1,307
已完成
3 期
Efficacy and Safety of Two Dry Power Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of AsthmaAsthmaNCT00975741Mantecorp Industria Quimica e Farmaceutica Ltd.97