EUCTR2017-003330-91-BG进行中（未招募）1 期
A pharmacokinetic and pharmacodynamic, randomised, single dose, cross-over, partially blinded study to compare the systemic exposure and the efficacy of a fixed-dose combination of Budesonide-Salmeterol DPI capsule 75-25 µg, Budesonide-Salmeterol DPI capsule 75-12.5 µg, Budesonide-Salmeterol DPI capsule 75-6.25 µg delivered by the Axahaler® versus Serevent® Diskus® 50 µg + Pulmicort® Turbohaler® 100µg co-administration in asthmatic children
aboratoires SMB S.A.0 个研究点目标入组 48 人开始时间: 2017年10月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •1.1.Male or premenarchal female subjects aged between 6 and 11 years, inclusive.
- •2.Caucasian.
- •3.Asthma diagnosed according to the GINA guidelines based on symptoms typical of childhood asthma, within at least 3 months prior to screening.
- •4.Subject presenting an increase in FEV1 of at least 12% of the FEV1 predicted value at reversibility test after 200µg of salbutamol at screening visit. If the level of reversibility is not achieved at screening, 1 repeat measurement of reversibility is allowed during the screening period within seven days after Visit 1 if there is reasonable belief that the patient can achieve the expected reversibility.
- •5.Patients not weighing less than 19 kg
- •6.Body mass index (BMI) within the 5th to 95th percentile of the BMI charts/tables recommended by the world health organization (WHO) based on stature-for-age and weight-for-age and by gender. (Charts presented in appendix 18.6)
- •7.Present a peak inspiratory flow =60L/min with the Axahaler®
- •8.Able to comply with all study procedures, including the use of study inhalers (AXAHALER®, DISKUS®, TURBOHALER®) and spirometer. Note: Since formal training and test for the correct handling of the DISKUS® and TURBOHALER® inhalers could not be provided the Investigator should check if the child understands the instructions provided for the inhalers use and is aware of their proper use. Willing to withhold the use of short acting ß-agonists for at least 6 hours prior to the screening visit and at least 6 hours prior to each study visit.
- •9.Written informed consent for the patient to participate in the study by the parent(s) or legal guardian(s) as applicable and if possible - a written assent by the patient.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •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.Drug addiction or excessive use of xanthine containing beverages (5 cups of tea, coffee, cacao, cola, ice tea)
- •2.Severe, life-threatening asthma or hospitalisation for an asthma exacerbation within 3 months prior to the screening visit and hospitalisation for a related disorder (pneumothorax, bronchopneumonia etc) in the past 3 months
- •3.Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormality, or disease
- •4.Respiratory tract infection requiring treatment with antibiotics within 4 weeks prior to the screening visit
- •5.Any significant upper and lower respiratory infection (other than asthma) within the previous 4 weeks before screening visit
- •6.Pure seasonal asthma and/ or a history of seasonal exacerbation of asthma
- •7.Use of any of the prohibited medications as detailed in the concomitant medication section 10.9
- •8. Clinical evidence of candidiasis or other fungal airway infection at the screening visit
- •9.Participation in any other clinical trial within 3 months of the screening visit
- •10.Blood donation within 3 months before the screening visit
- •11.Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the study
- •12Patients with any sensitivity or allergy to any of the products (including excipients) used within this clinical trial
- •13Patient known to have, or at risk of contracting, human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C or patients with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab)
- •14Patients with diabetes mellitus
- •15Subjects previously enrolled into the current study.
- •16First-degree relative of a study investigator, or of employee of the clinical study site or of the sponsor
研究者
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