EUCTR2015-000841-22-DK进行中（未招募）不适用
A randomised, double-blind, two-way crossover study to investigate the effect of inhaled fluticasone furoate on short-term growth in paediatric subjects with asthma
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 60 人开始时间: 2015年5月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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. Aged 5 years to less than 12 years at Visit 1.
- •At least 15 (25%) children of the total study population must be aged 5 to less than 8 years.
- •2. Male or pre-menarchial female subjects.
- •3. Subjects must be pre-adolescent without any signs of puberty (Tanner Stage 1).
- •4. Normal range for their height and weight. Weight and height measurements should fall within the percentile range 3-97% of normal values for age according to Danish growth charts.
- •5. Have a documented diagnosis of persistent asthma, as defined by the National Institutes of Health (National Institutes of Health, 2007) for at least 3 months prior to the Screening Visit.
- •6. A pre-bronchodilatory FEV1 at Visit 1 (Screening) = 80% predicted. There should be no SABA use within 4 hours of this measurement.
- •7. Using one of the following asthma therapies prior to entry into the study:
- •Short acting beta-agonist (SABA) inhaler alone (e.g. salbutamol) on an as required basis and/or
- •Regular non-ICS controller medications for asthma (e.g. cromones or leukotriene receptor antagonists) and/or
- •Previously treated with ICS (equipotent to inhaled budesonide = 400 mcg total daily dose).
- •There must be no ICS use within 2 weeks of Visit 1 (Screening).
- •8. Able to replace their current SABA treatment with study supplied rescue SABA provided at Visit 1 for use as needed for the duration of the study.
- •9. Written informed consent from at least one parent/care giver (legal guardian) and accompanying informed assent from the subject (where the subject is able to provide assent) prior to admission to the study.
- •If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement. The study investigator is accountable for determining a child's capacity to assent to participation in a research study, taking into consideration any standards set by the responsible IEC.
- •Subject and their legal guardian(s) understand that the study requires them to be treated on an outpatient basis.
- •Subject and their legal guardian(s) understand that they must comply with study medication and study assessments including recording of PEF and rescue SABA use, attending scheduled study visits, and being accessible by a telephone call
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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. A history of life-threatening asthma defined for this protocol as an asthma episode that required intubation, hypercapnea requiring noninvasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode(s).
- •2. Subjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a depot corticosteroid injection or ER attendance (within 3 months) or requiring hospitalization for asthma (within 6 months) prior to screening.
- •3. Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis).
- •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 Visit 1 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 the study.
- •5. Any fracture in the leg to be measured within 6 months prior to the screening visit.
- •6. Any metabolic disorders or other diseases that may impact on normal growth patterns.
- •7. No major surgery requiring general anaesthesia for at least 3 months prior to the screening visit.
- •8. No febrile illnesses with temperature >39 degrees Celsius for more than five consecutive days within the week preceding the Screening Visit.
- •9. Any significant abnormality or medical condition identified at the screening medical assessment (including serious psychological disorder) that in the Investigator's opinion, preclude entry into the study due to risk to the subject or that may interfere with the outcome of the study.
- •10. Clinical visual evidence of candidiasis at Visit 1 (Screening).
- •11. Use of any of the prohibited medications listed in Section 6.11 of the protocol.
- •12. Strenuous physical exercise within 3 hours of Visit 1 (Screening)
- •13. Drug allergies: Any adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the ELLIPTA Inhaler (i.e., lactose, FF).
- •14. Milk Protein Allergy: History of severe milk protein allergy.
- •15. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •16. Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.
- •17. Unable to use the ELLIPTA inhaler and peak flow meter correctly
- •19. The Parent or Guardian has a history of psychiatric disease, intellectual deficiency, substance abuse or other condition (e.g. inability to read, comprehend or write) which may affect:
- •validity of consent to participate in the study
- •adequate supervision of the subject during the study
- •compliance of subject with study medication and study procedures (e.g.completion of daily diary, attending scheduled clinic visits)
- •subject safety and well-being
- •20. Children in care: Children who are wards of the government or state are not eligible for participation in this study.
研究者
相似试验
已完成
不适用
A randomized, double-blind, two-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single subcutaneous administration of LA-EP2006 and a single subcutaneous administration of Neulasta® (EU-authorized) in healthy subjectsinfectionreduced white blood cell count1001884910027665NL-OMON43539Hexal AG184
进行中（未招募）
1 期
Comparison of two daily dose regimens of tiotropium 5 µg once daily and tiotropium 2.5 µg twice daily for 4 weeks on top of maintenance therapy with an inhaled corticosteroid controller medicatioMedDRA version: 15.0Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2012-001873-10-SIBoehringer Ingelheim RCV GmbH & Co KG92
进行中（未招募）
不适用
Comparison of two daily dose regimens of tiotropium 5 µg once daily and tiotropium 2.5 µg twice daily for 4 weeks on top of maintenance therapy with an inhaled corticosteroid controller medicatioEUCTR2012-001873-10-DEBoehringer Ingelheim Pharma GmbH & Co. KG92
进行中（未招募）
不适用
Comparison of two daily dose regimens of tiotropium 5 µg once daily and tiotropium 2.5 µg twice daily for 4 weeks on top of maintenance therapy with an inhaled corticosteroid controller medicatioEUCTR2012-001873-10-HUBoehringer Ingelheim RCV GmbH & Co KG92
进行中（未招募）
不适用
Comparison of two daily dose regimens of tiotropium 5 µg once daily and tiotropium 2.5 µg twice daily for 4 weeks on top of maintenance therapy with an inhaled corticosteroid controller medicatioEUCTR2012-001873-10-ATBoehringer Ingelheim RCV GmbH & Co KG92