NCT00941798已完成2 期
A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,283
- 试验地点
- 4
- 主要终点
- Time to First Serious Asthma Exacerbation
研究概览
简要总结
Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.
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
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a documented diagnosis of persistent asthma and who were currently treated with or qualified for treatment with both ICS and long-acting beta2-agonist (LABA) combination
- •Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥ 12% or ≥ 200 mLs within 30 minutes after administration of short-acting beta2-agonist (SABA)
- •Patients with an FEV1 ≥ 50% of predicted normal
排除标准
- •Patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD)
- •Patients who had an asthma attack/exacerbation requiring hospitalization/emergency room visit or respiratory tract infection within 1 month prior to randomization
- •Patients who had ever required ventilator support for respiratory failure
- •Patients with diabetes Type I or uncontrolled diabetes Type II
- •Patients with concomitant pulmonary disease
- •Patients with certain cardiovascular co-morbid conditions
- •Patients with any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
QMF149 Twisthaler® 500/400
Experimental
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
干预措施: QMF149 Twisthaler® (Drug)
Mometasone Twisthaler®
Active Comparator
Mometasone Twisthaler®, 400 µg QD
干预措施: Mometasone Twisthaler® (Drug)
结局指标
主要结局
Time to First Serious Asthma Exacerbation
时间窗: Up to 21 months
Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.
次要结局
- Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.(up to 21 months)
- Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids(Up to 21 months)
- Number of Patients With at Least One Asthma Worsening Post-baseline(Up to 21 months)
- Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit(Baseline to the end of treatment (varying durations, up to 21 months))
- Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit(Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose)
- Change From Baseline in Forced Vital Capacity (FVC) at Final Visit(Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose)
- Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period(Baseline to the end of treatment (varying durations, up to 21 months))
- Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime(Baseline to the end of treatment (varying durations, up to 21 months))
- Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime(Baseline to the end of treatment (varying durations, up to 21 months))
- Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime(Baseline to the end of treatment (varying durations, up to 21 months))
- Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit(Baseline to the end of treatment (varying durations, up to 21 months))
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With AsthmaAsthmaNCT02554786Novartis Pharmaceuticals2,216
已完成
3 期
Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With AsthmaMild AsthmaNCT02892344Novartis Pharmaceuticals802
已完成
3 期
Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With AsthmaAsthmaNCT02571777Novartis Pharmaceuticals3,092
已完成
3 期
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)NCT01574651Novartis Pharmaceuticals934
已完成
3 期
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow LimitationChronic Obstructive Pulmonary Disease (COPD)NCT01682863Novartis Pharmaceuticals614