EUCTR2014-001946-10-BG进行中（未招募）不适用
A randomised, single dose, open label, two-period crossover study evaluating bioequivalence of salmeterol xinafoate HFA pMDI 25µg per actuation manufactured by Cipla Ltd, India (test product) with salmeterol xinafoate HFA pMDI 25µg per actuation (Serevent™ Evohaler™), supplied by Allen and Hanburys, UK (reference product) when administered by a volumatic spacer to paediatric asthma subjects.
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
- Cipla Ltd.
- 入组人数
- 80
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. Informed consent by the subject’s parent /legal guardian/Assent (if possible also by the subject) given in a written form after being provided with detailed information about the nature, risks and scope of the clinical trial as well as the expected desirable and adverse effects of the drug.
- •2. Male or female (pre-menarchal and pre–pubescent) subjects aged 4 to 11 years.
- •3. Subjects not weighing less than 12 Kgs.
- •4. Body mass index (BMI) within the 5th to 125th percentile of the appropriate BMI designated charts based on stature-for-age and weight-for-age and by gender.
- •5. Subjects, who are stable on treatment with same dose of ICS and salbutamol sulphate as needed for the past 2 weeks prior to screening.
- •6. Subjects with physician diagnosed asthma as per the GINA guidelines.
- •7. Subjects aged 6 to 11 years with a FEV1 = 80% predicted at screening or subjects aged 4 to 5 years with a PEF >80% predicted or >85% of their personal best.
- •8. Subjects with no evidence of significant underlying disease other than asthma during the pre-study screening evaluation, medical history, laboratory tests, vital signs, and physical examination.
- •9. Subjects who agree to avoid strenuous physical exertion for at least 48 hours prior to dosing of each study period.
- •10. Subjects agree to abstain from consuming grapefruit or its products for at least 96 hours prior to dosing and until the last blood sample is withdrawn in a particular period
- •11. Subjects agree to abstain from consuming citrus fruits or their products and xanthine containing products (chocolate, tea, coffee or cola drink), for at least 2 hours prior to dosing and until the last blood sample is withdrawn in a particular period.
- •12. Subjects who agree to be available for the entire duration of the study and have the ability to understand and communicate effectively with the investigators and study personnel.
- •13. Subjects who are able to correctly use the pMDI with the volumatic spacer device, following training received from qualified site personnel.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •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. History of severe or life threatening asthma defined as any asthma episode associated with hypercapnea, intubation or admission to an intensive care unit.
- •2. Any use of salmeterol within 4 weeks prior to the Visit S.
- •3. Unstable asthma as evidenced by any change in asthma therapy within 2 weeks prior to screening or use of more than 4 puffs of rescue medication (salbutamol sulphate) per day within 1 week prior to screening.
- •4. Unstable asthma as evidenced by any change in asthma therapy within the last 3 months or admission to hospital due to asthma during or within the last 6 months before subject’s participation in the trial.
- •5. More than 1 short course of oral/systemic corticosteroids within 6 months preceding the Visit S, or any oral/systemic corticosteroids in the preceding 3 months.
- •6. Evidence of active concomitant pulmonary disease other than asthma (subjects with stable allergic rhinitis will be permitted as long as there are no changes in the treatment and the medications do not interfere with the analytical assay methods).
- •7. Subjects who have suffered any clinically significant illness in the two weeks prior to dosing or who have been hospitalised within 3 months preceding the start of the study.
- •8. Acute upper respiratory tract infection (URTI) that has not resolved within 4 weeks of the Visit S.
- •9. Acute lower respiratory tract infection (LRTI) that has not resolved within 8 weeks of the Visit S.
- •10. History of any clinically significant disease including but not limited to concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, gastrointestinal, psychological, haematological, neurological, or immunological).
- •11. Clinically significant abnormal laboratory values.
- •12. Subjects who have a history of severe food allergy.
- •13. Known or suspected hypersensitivity to salmeterol xinafoate or any other constituents of the investigational products.
- •14. Use of any medication (prescription, non-prescription or herbal) other than salbutamol sulphate and the subject’s regular ICS within 4 weeks prior to the first dose of study medication unless complete elimination from the body can be assumed for the drug on the basis of the terminal elimination half-life (at least 5 times the elimination half-life to be elapsed) until the first dose of study medication.
- •15. Use of drugs which can specifically induce or inhibit enzyme Cytochrome P450 3A4 (CYP3A4) within 4 weeks prior to the first dose of the study medication.
- •16. Treatment with any investigational drug in the 3 months preceding the Visit S or 5 times the elimination half-life of that drug, whichever is longer.
- •17. Donation of blood in excess of 50 mL within 90 days prior to receiving the first dose of study medication.
- •18. Legal incapacity or other circumstances that render the subject’s parent or legal guardian unable to understand the nature, scope and possible consequences of the study.
- •19. In the investigator’s opinion, subjects unlikely to comply with the study procedures.
- •20. Subjects previously randomised into this study.
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