A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6,250
- 试验地点
- 1
- 主要终点
- Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period
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 children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
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 May 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent to participate in the study
- •Age 4-11 years old
- •Male or eligible female - Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation
- •Asthma diagnosis for at least 6 months
- •Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS
- •A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids.
- •History of at least once occurrence of asthma exacerbation within the prior 12 months
- •Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)
排除标准
- •History of life-threatening asthma
- •Unstable asthma
- •Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
- •Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
- •Respiratory infection
- •Subjects with only exercise-induced asthma
- •An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
- •Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months
- •Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system
- •Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements
- •Participation in an interventional study or used any investigational drug for any disease state within the last 30 days
- •Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication
- •Severe hypersensitivity to cow's milk proteins
- •Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics
- •Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
- •Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
- •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
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
干预措施: ADVAIR 100/50mcg (Drug)
ADVAIR 250/50mcg
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
干预措施: ADVAIR 250/50mcg (Drug)
FLOVENT 100mcg
fluticasone propionate (100) twice daily (AM and PM) for 6 months
干预措施: FLOVENT 100mcg (Drug)
FLOVENT 250mcg
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
干预措施: FLOVENT 250mcg (Drug)
结局指标
主要结局
Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period
时间窗: From Day 1 up to 6 months
Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.
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 6 months
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. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.
次要结局
- Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period(From Day 1 up to 6 months)
- Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period(From Day 1 up to 6 months)
- Percentage of Rescue-free Days Over the 6-month Study Treatment Period(From Day 1 up to 6 months)
- Percentage of Asthma Control Days Over the 6-month Study Treatment Period(From Day 1 up to 6 months)
- Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.(From Day 1 up to 6 months)
- Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period(From Day 1 up to 6 months)