SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11,751
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
研究概览
简要总结
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.
详细描述
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.
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)
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
- •Provided consent to participate in the study
- •Male or female, 12 years of age and older
- •Clinical diagnosis of asthma for at least 1 year prior to the randomization
- •Clinic PEF of greater than or equal to 50% of predicted normal value
- •Subject must be appropriately using one of the treatments for asthma listed in the protocol
- •Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler
- •Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
- •requiring treatment with systemic corticosteroids
- •an asthma-related hospitalization
排除标准
- •History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
- •Concurrent respiratory disease other than asthma
- •Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
- •Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
- •Presence of a bacterial or viral respiratory infection that is not resolved at randomization
- •An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization
- •More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
- •Subject must not meet unstable asthma severity criteria as listed in the protocol
- •Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
- •Pregnancy, breast-feeding or planned pregnancy during the study
- •A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
研究组 & 干预措施
ADVAIR 100/50mcg
experimental drug
干预措施: ADVAIR 100/50mcg (Drug)
ADVAIR 250/50mcg
experimental drug
干预措施: ADVAIR 250/50mcg (Drug)
ADVAIR 500/50mcg
experimental drug
干预措施: ADVAIR 500/50mcg (Drug)
FLOVENT 100mcg
active comparator
干预措施: FLOVENT 100mcg (Drug)
FLOVENT 250mcg
active comparator
干预措施: FLOVENT 250mcg (Drug)
FLOVENT 500mcg
active comparator
干预措施: FLOVENT 500mcg (Drug)
结局指标
主要结局
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
时间窗: From Day 1 up to 26 weeks
Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.
Number of Participants Experiencing at Least One Asthma Exacerbation
时间窗: From Day 1 up to 26 weeks
An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
次要结局
- Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death(From Day 1 up to 26 weeks)
- Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation(From Day 1 up to 26 weeks)
- Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours(From Day 1 up to 26 weeks)