EUCTR2012-000754-55-Outside-EU/EEA进行中（未招募）不适用
A randomized, double-blind, repeat dose, two period crossover study toevaluate the safety and tolerability, pharmacokinetics, andpharmacodynamics of inhaled fluticasone furoate/vilanterol 100/25 mcgin children aged 5 to 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
- •A subject will be eligible for inclusion in this study only if all of the
- •following criteria apply:
- •1. Healthy as determined by a study physician, based medical history,
- •physical examination, laboratory testing, and ECG; with no significant medical condition apart from asthma, eczema, or rhinitis. A subject with a clinical abnormality or laboratory parameters outside the reference range for this study may be included if the Investigator and GSK Medical Monitor agree the finding is unlikely to introduce
- •additional risk factors or interfere with the study procedures.
- •2. Male and pre-menarchial female subjects aged 5 to less than 12
- •years on the last planned treatment day are eligible for this study. Pre-menarchial females are defined as any female who has not begun menses and is considered Tanner Stage 2 or less.
- •3. Diagnosis of asthma at least 6 months prior to screening.
- •4. Stable asthma therapy (fluticasone propionate, total daily dose less
- •than or equal to 400 mcg or equivalent) and short acting beta-agonist
- •(SABA) inhaler for at least 4 weeks prior to screening.
- •5. Subjects must be controlled on their existing asthma treatment at
- •screening, which will be continued during the run-in, washout and runout periods (but not during 25 active treatment periods). Control is defined as a Childhood Asthma Control Test score of >19 and PEF = 75% predicted.
- •6. Subjects must demonstrate an ability to accept and effectively use a
- •demonstration inhaler from the demonstration kits provided.
- •7. Subjects must weigh at least 20 kg.
- •8. The subject and parent/guardian are able to understand and comply
- •with protocol requirements, instructions, and protocol stated restrictions. The parent or guardian must have the ability to read, write, and record diary information collected throughout the study. The parent or guardian must have the ability to manage study drug administration and PEF assessments.
- •9. At least one parent/guardian has signed and dated the written
- •informed consent prior to admission to the study. This will be accompanied by informed assent from the subject for children aged 7 to 11 years.
- •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 with a history of life-threatening asthma, an asthma
- •exacerbation requiring systemic corticosteroids or ER attendance (within 3 months) or requiring hospitalization (within 6 months) prior to screening.
- •2. Subjects with any medical condition or circumstance making the
- •volunteer unsuitable for participation in the study.
- •3. Culture-documented or suspected bacterial or viral infection of the
- •upper or lower respiratory tract, sinus, or middle ear, not resolved
- •within 4 weeks of screening leading to a change in asthma management; or, in the opinion of the investigator, is likely to affect the subject's asthma status or ability to participate in the study.
- •4. Clinical visual evidence of oral candidiasis at screening.
- •5. Subjects currently receiving (or have received within 4 weeks of
- •screening) asthma therapies including theophyllines, long-acting inhaled beta-agonists, oral beta-agonists, or who have changed their asthma medication within 4 weeks of screening.
- •6. Significant abnormality of rate, interval, conduction or rhythm in the
- •12-lead ECG, determined by the investigator in conjunction with the age and gender of the child and the assessment provided by the remote analysis service.
- •7. QTcF > 450 msec or an ECG not suitable for QT measurement (e.g.
- •poorly defined termination of the T wave).
- •8. AST, ALT, alkaline phosphatase and bilirubin > 1.5xULN (isolated
- •bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •9. A known or suspected sensitivity to any constituents of the novel dry
- •powder inhaler (i.e. lactose or magnesium stearate) (e.g. history of severe milk protein allergy)
- •10. Any adverse reaction including immediate or delayed
- •hypersensitivity to any beta-2-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid therapy.
- •11. Use of prescription or non-prescription drugs, including vitamins,
- •herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- •12. Consumption of red wine, seville oranges, grapefruit or grapefruit
- •juice, and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- •13. The subject has participated in a clinical trial and has received an
- •investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
- •14. Exposure to more than four new chemical entities within 12 months
- •prior to the first dosing day.
- •15. Where participation in the study would result in donation of blood
- •or blood products in excess of the lesser of 50mL or 3mL per kilogram within a 56 day period.
- •16. Parent/guardian has a 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.
- •17. Unwillingness or inability of the subject or parent/guardian to
- •follow the procedures outlined in the protocol.
- •18. Subject who is mentally or legally incapacitated.
- •19. Children who are wards of the state or government.
- •20. A subject will not be eligible for this study if he/she is an immediate family m
研究者
相似试验
招募中
1 期
A study to evaluate the effect of food on the pharmakokinetics and cardiac function in male and female healthy volunteers who have been administered cannibidiol.ACTRN12619000443190Kalytera Australia Pty Ltd32
Unknown
不适用
Comparative pharmacokinetic and Pharmacodynamic trial of Wosulin R Insulin Injection (in comparision with Human Actrapid HM penfil insulin injection) in healthy human adult volunteersCTRI/2015/05/005801Wockhardt Ltd India48
已完成
1 期
A phase I biosimilar study to compare the pharmacokinetics, safety and tolerability of Abcertin, and EU-sourced Cerezyme® in healthy volunteers following a single infusion via the veins.ACTRN12619001399189ISU Abxis Co., LTD42
进行中（未招募）
1 期
A double-blind, multi-centre phase II dose finding study of ODX (Osteodex) in for patients with castration resistant prostate cancer and skeletal metastatesMetastatic Castration Resistant Prostate Cancer (CRPC) and skeletal metastasesMedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005666-37-FIDexTech Medical AB60
进行中（未招募）
1 期
A double-blind, multi-centre phase II dose finding study of ODX (Osteodex) in for patients with castration resistant prostate cancer and skeletal metastatesEUCTR2015-005666-37-LVDexTech Medical AB60