A repeat-dose, open-label, randomized, incomplete block design in pediatric subjects with asthma, ages 4 - 11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following Advair® HFA 45/21 mcg (2 inhalations), Advair HFA 45/21 mcg (2 inhalations) with Aerochamber Plus Spacer and Advair Diskus 100/50 twice daily.

GlaxoSmithKline Research & Development0 个研究点目标入组 24 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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•1. Male and pre-menarchial female subjects with mild asthma (PEF > 75% predicted) aged 4 - 11 years are eligible for this study. Pre-menarchial females are defined as any female who has yet to begin menses and is considered Tanner Stage 2 or less; any female who begins menstruation during the course of the study will be withdrawn.
•2. Apart from asthma(as defined by GINA, 2005), subjects should be healthy and suffer from no other significant medical conditions.
•3. Subjects must weigh at least 11 kg and have a BMI of 14-24 kg/m2 for inclusion in this study.
•4. Subjects and/or parents must demonstrate ability to accept and effectively use the MDI, Aerochamber Plus Spacer and DISKUS devices using the demonstration kits provided to the site.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•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

•1. Any clinically relevant abnormality identified on the screening medical assessment
•2. Any medical condition or circumstance making the volunteer unsuitable for participation in the study
•3. Subjects should not be on a long-acting beta-agonist and asthma control should be with regular or intermittent non-steroidal asthma medication, such as short-acting
•beta-agonist as required or montelukast, for at least three months prior to entry in to the study.
•Inhaled corticosteroids will be excluded for 6 weeks prior to the Screening Visit and throughout the study until study discharge at Session 2. Investigators should not discontinue ICS therapy if there is a significant possibility that this will result in deterioration in asthma control
•Topical corticosteroids equivalent to >1% hydrocortisone cream or ointment at any time from Screening Visit through discharge at the end of Session 2
•4. A subject has been using Corticosteriods in any of the delivery systems as indicated below:
•Oral or parenteral corticosteroids used within 10 weeks prior to the Screening Visit or during the study until study discharge in Session 2 or has used more than 2 courses during 6 months prior to the Screening Visit
•Intranasal corticosteroids within 2 weeks before Screening Visit and during the study until study discharge in Session 2

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