A multicentre, randomized, double-blind, double-dummy, active-controlled, parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate 1mg twice daily compared with oral prednisone administered for 7 days to Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 251 人开始时间: 2016年8月3日最近更新: 2016年8月8日

适应症

试验速览

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•- Chinese male and female pediatric or adolescent subjects aged 4 to 16 years, inclusive
•- Subjects have an established diagnosis of asthma
•- The definition of asthma. According to Chinese Guideline for the diagnosis and optimal management of asthma in children [Respiratory branch of pediatric society,Chinese Medical. Association. 2008, revised version], the subjects can be diagnosed when meeting the criteria. The diagnosis criteria is listed in the protocol.
•- The severity of an acute exacerbation of asthma is defined as PEF of 50% to 75% predicted via a peak flow meter, with a clinical scoring index of =2. The clinical scoring index represents the sum of the score for each of four signs: respiratory rate (0=low to 3=high, dependent on age), wheezing (0=none to 3=severe), inspiration/expiration ratio (0=2:1 to 3=1:3), and accessory muscle (0=none to 3=marked use).
•- Subjects can properly use a mini-wright peak flow meter, nebulizer and MDI with/without a spacer, and accurately complete a diary card with parental assistance, if required.
•- Subjects’ parents/guardians are willing to give written informed consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 251
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Severe respiratory dysfunction.
•- History of mechanical ventilation due to respiratory failure.
•- Admission to hospital due to respiratory disease within the previous 2 weeks, including asthmatic exacerbations.
•- Clinical or lab evidence of a serious, uncontrolled systemic disease or presence of any disease likely to interfere with the objectives of this study, such as pulmonary cystic fibrosis and bronchopulmonary dysplasia.
•- Known or suspected hypersensitivity to glucocorticosteroids or ß2 agonists.
•- Clinical visual evidence of oral candidiasis at Visit1.
•- Use of the medications below in Table 1 according to the following defined time intervals prior to presentation. The list is provided in the protocol.

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