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 - VESTRI

GlaxoSmithKline Research & Development Limited0 个研究点目标入组 6,200 人开始时间: 2012年4月12日最近更新: 2014年2月17日

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•French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
•1\. Informed consent
•Subject’s legal guardian must be able and willing to give written informed consent to take part in the study.
•If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement.
•Subject and their legal guardian understand that the study requires them to be treated on an outpatient basis.
•Subject and their legal guardian understand that they must comply with study medication and study assessments including recording of symptom scores and rescue albuterol/salbutamol use, attending scheduled study visits, and being accessible by a telephone call.
•2\. Age: 4\-11 years of age at Visit 1
•3\. Gender: 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. All females of childbearing potential must have a negative urine pregnancy test result prior to randomization to
•continue in the study. Females who become pregnant during the course of the study will be discontinued and the pregnancy outcome followed
•4\. Asthma diagnosis: Asthma, defined by the regional asthma guidelines (i.e., NIH,

•1\. History of life\-threatening asthma: Defined for this protocol as an asthma episode
•that required intubation, hypercapnea requiring non\-invasive ventilatory support,
•respiratory arrest, hypoxic seizures or asthma\-related syncopal episode(s).
•2\. Unstable asthma at Visit 1\.
•3\. Subjects who are currently receiving high\-dose ICS or ICS/LABA therapy to treat
•asthma symptoms.
•4\. 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.

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