EUCTR2006-001417-16-LV进行中（未招募）不适用
A randomized, double-blind, parallel group study evaluating the safety of fluticasone propionate/salmeterol 100/50mcg HFA (2 inhalations of 50/25mcg) twice daily compared with fluticasone propionate 100mcg HFA (2 inhalations of 50mcg) twice daily in subjects 4-11 years of age with persistent asthma.
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 300 人开始时间: 2006年8月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Type of Subject: A subject must be treatable on an outpatient basis.
- •Age: A subject must be 4-11 years of age at Visit 1.
- •Gender: Male or pre-menarchal female
- •Disease: Each subject must have a diagnosis of asthma which has required physician-prescribed pharmacotherapy for at least two months prior to Visit 1
- •Severity of Disease: At Visit 1, after withholding asthma medications, subjects 6-11 years of age must demonstrate a baseline best morning pre-albuterol (salbutamol) clinic FEV1 greater than or equal to 60% of the Polgar predicted value and subjects 4 and 5 years of age must demonstrate a best morning pre-albuterol (salbutamol) clinic AM PEF greater than or equal to 60% of the Polgar predicted value
- •Reversibility Component: A subject must have historical documentation of an increase in FEV1 or PEF of greater than or equal to 12% within 30 minutes following administration of albuterol (salbutamol) (MDI or nebulized) or levalbuterol within 24 months prior to Visit 1, or current reversible airways disease as demonstrated at Visit 1 by an increase in FEV1 of than or equal to 12% over the pre-albuterol (salbutamol) inhalation aerosol FEV1 (6-11 years) or PEF (4 and 5 years) within 30 minutes after the inhalation of 2-4 puffs (180-360mcg) or one nebulized treatment of albuterol (salbutamol)
- •Concurrent Anti-Asthma Therapy: Subjects are eligible to participate in the trial if they have been using an inhaled corticosteroid at a consistent dose, within the range specified in the protocol, for at least one month prior to Visit 1
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Life Threatening Asthma: A subject must not have life-threatening asthma. Life threatening asthma is defined for this protocol as a history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest or hypoxic seizures, or asthma-related syncopal episode(s). A subject must not have been hospitalized two or more times in the last year due to asthma
- •Asthma Medications: Certain Asthma medications as listed in protocol must not have been used prior to Visit 1 for the required interval indicated in the protocol, and not taken during the study.
- •Corticosteroid Therapy: The use of any corticosteroid medication other than study medication, intranasal corticosteroids, and low potency (of greater than or equal to 1%) topical hydrocortisone cream or ointment during the study is prohibited
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