EUCTR2012-000753-31-Outside-EU/EEA进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, two-waycrossover 14-day study to invstigate the safety, tolerability,pharmacodynamics and pharmacokinetics of repeat dose inhaled fluticasone furoate 100 mcg in children aged 5-11 years with persistent asthma - Not Applicable
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
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
- •1. Male and pre-menarchial female subjects aged 5–11 years on the last planned
- •treatment day 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.
- •2. Diagnosis of asthma at least 6 months prior to screening.
- •3. Patients must be controlled on their existing asthma treatment at screening as defined
- •by a Childhood Asthma Control Test score of >19 and PEF =80% predicted.
- •4. Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from
- •no other significant medical conditions.
- •5. Subjects must be taking a stable regimen of a short acting beta-agonist inhaler on an
- •as-need basis for at least 4 weeks prior to screening.
- •6. Subjects must weigh at least 15 kg.
- •7. Subjects must demonstrate ability to accept and effectively use the fluticasone
- •furoate devices using the demonstration kits provided to the site.
- •8. Subjects and parents/guardians must be able to understand and comply with protocol
- •requirements, instructions and protocol-stated restrictions. Parents/guardians must
- •have the ability to read, write and record diary information collected throughout the
- •study. They must also have the ability to manage study drug administration and PEF
- •assessments.
- •9. A signed and dated written informed consent from at least one parent/guardian, and accompanying informed assent from the subject prior to admission to the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 26
- •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
排除标准
- •1. Subjects who have changed their asthma medication within 4 weeks of screening or
- •subjects currently being treated with inhaled corticosteroids or have received such
- •treatment within 4 weeks of screening. In addition, subjects currently receiving (or
- •have received within 4 weeks of screening) any of the following asthma therapies:
- •theophyllines, long-acting inhaled beta-agonists or oral beta-agonists.
- •2. Any medical condition or circumstance making the volunteer unsuitable for
- •participation in the study (e.g. history of life-threatening asthma).
- •3. Any clinically relevant abnormality identified on the screening medical assessment,
- •including asthma exacerbation requiring systemic corticosteroids (oral,
- •intramuscular, intravenous) or emergency room attendance within 3 months or
- •asthma exacerbation requiring hospitalization within 6 months prior to screening.
- •4. Culture-documented or suspected bacterial or viral infection of the upper or lower
- •respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening
- •and led to a change in asthma management or, in the opinion of the Investigator, is
- •expected to affect the subject’s asthma status or the subject’s ability to participate in
- •5. Clinical visual evidence of oral candidiasis at screening.
- •6. Parent/guardian has history of psychiatric disease, intellectual deficiency, substance
- •abuse, or other condition (e.g., inability to read, comprehend and write) which will
- •limit the validity of consent to participate in this study.
- •7. Any adverse reaction including immediate or delayed hypersensitivity to any beta-2-
- •agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid
- •8. Known or suspected sensitivity to the constituents of the novel dry powder inhaler
- •(i.e., lactose or magnesium stearate), for example, history of severe milk protein
- •9. A subject will not be eligible for this study if he/she is an immediate family member
- •of the participating Investigator, sub-Investigator, study coordinator, or employee of
- •the participating Investigator.
- •10. Children who are wards of the state or government.
- •11. Evidence of clinically significant abnormality in the 12-lead ECG at screening, as
- •i. Ventricular rate <65 bpm or >115 bpm if aged 5–7 years.
- •ii. Ventricular rate <55 bpm or >110bpm if aged 8–11 years.
- •iii. PR interval >160 msec if aged 5–7 years.
- •iv. PR interval >170 msec if aged 8–11 years.
- •v. QRS >100 msec.
- •vi. Evidence of Mobitz II second degree or third degree AV block.
- •vii. Evidence of =2 unifocal ventricular ectopic beats, couplets,
- •bigeminy, trigeminy or multifocal premature ventricular
- •complexes on three ECG traces.
- •viii. QTcB >450 msec or an ECG that is not suitable for QT
- •measurements (e.g. poor defined termination of the T wave).
- •ix. Right or left complete bundle branch block.
- •x. Clinically significant conduction abnormalities (e.g. left bundle
- •branch block, Wolff-Parkinson-White syndrome).
- •xi. Clinically significant arrhythmias (e.g. atrial fibrillation, atrial
- •flutter, ventricular tachycardia).
- •xii. Non-sustained VT (3 or more consecutive ventricular beats greater
- •than 100 bpm).
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