A Randomized, Double-blind, Double-dummy, 4-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of Two Doses of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 739
- 试验地点
- 1
- 主要终点
- Trough Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients 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
- Double (Participant, Investigator)
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
- •Males or females who were ≥ 12 years old at the time informed consent was obtained
- •Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally met the following criteria
- •Patients who were receiving ICS treatment up to the maximum dose per day as indicated in the corresponding package leaflet and also a stable ICS regimen for at least 4 weeks prior to screening (Visit 2).
- •Patients whose level of asthma control according to GINA 2010 guideline was "Partly Controlled" or "Uncontrolled" at screening (Visit 2).
- •Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at screening (Visit 2).
- •Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit
- •Patients who were confirmed as "ICS sensitive" by ACQ-5 and FEV1 at Visit
- •Key exclusion criteria included:
- •Patients diagnosed with COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease, updated
- •Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.
- •Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
- •Patients with seasonal allergy which is likely to deteriorate his/her asthma condition during the study period judged by the investigator.
- •Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).
- •Patients who have had an emergency room visit for an asthma attack/exacerbation within 4 weeks prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).
- •Patients who have ever required intubation for a severe asthma attack/exacerbation.
- •Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1, or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Mometasone furoate 800 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.
干预措施: Twisthaler (Device)
Mometasone furoate 80 μg
Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks.
干预措施: Mometasone furoate (Drug)
Mometasone furoate 80 μg
Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks.
干预措施: Concept 1 (Device)
Mometasone furoate 200 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks.
干预措施: Mometasone furoate (Drug)
Mometasone furoate 200 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks.
干预措施: Twisthaler (Device)
Mometasone furoate 320 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.
干预措施: Mometasone furoate (Drug)
Mometasone furoate 320 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.
干预措施: Concept 1 (Device)
Mometasone furoate 800 µg
Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.
干预措施: Mometasone furoate (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Day 29
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.
次要结局
- Forced Vital Capacity (FVC) at All Time Points(Days 1, 8, 15, 22, 28 and 29 at all time points)
- Plasma Cortisol Concentrations(Baseline, days 1 and 28)
- Fractional Exhaled Nitric Oxide (FeNO)(Days 15 and 29)
- Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points(Days 1, 8, 15, 22, 28 and 29 at all time points)
- Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment(Baseline and 4 weeks)
- Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit(Baseline, days 8,15,22 and 29)
- Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment(Days 8, 15 and 22)
- Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points(Days 1, 8, 15, 22, 28 and 29 at all time points)
- Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment(Baseline and week 4)
- Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment(4 weeks)