EUCTR2010-018712-32-GB进行中（未招募）不适用
A Pilot Pharmacodynamic/Pharmacokinetic Study of SalmeterolXinofoate as a Dry Powder in Combination with Fluticasone in Patients with Asthma for Dose-Scale Bronchodilator Model Development.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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. Adult males and females = 18 years with BMI 19 to 32 kg/m2 (inclusive) and a bodyweight = 50 kg.
- •2. Patients with a clinical diagnosis of mild to moderate asthma (defined as satisfying
- •the Global Initiative in Asthma [GINA] definition of asthma or has satisfied in the
- •past and have a pre-bronchodilator forced expiratory volume in 1 second (FEV1)
- •>50% at Screening.
- •3. Patients must demonstrate = 15% reversibility (and a = 200 mL difference) from prebronchodilator FEV1 within 15 to 30 minutes of receiving up to 400 mcg salbutamol by MDI with spacer or up to 5 mg salbutamol by nebulizer at Screening.
- •4. Patients who if female, are not currently pregnant or breast feeding and are using
- •medically acceptable methods of contraception.
- •5. Patients whose clinical laboratory test results are not clinically relevant and are
- •acceptable to the Investigator.
- •6. Patients who are negative for HBsAg, hepatitis C antibody and HIV I and II test at
- •7. Patients who are negative for drugs of abuse and alcohol tests at screening and
- •8. Patients who are non-smokers for at least 3 months prior to screening.
- •9. Patients who have a < 10 pack-year smoking history.
- •10. Patients who are able and willing to give written informed consent.
- •11. Patients who are able to use an inhaled medical device, as demonstrated by the use of a flow loop assessment.
- •12. Medical history must be verified by either a personal physician or medical practitioner as appropriate.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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. Patients who do not conform to the above inclusion criteria.
- •2. Patients who have a clinically relevant history or presence gastrointestinal, renal,
- •hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric,
- •musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders which would preclude participation in the opinion of the
- •Investigator.
- •3. Patients who have a clinically relevant medical or surgical history that would preclude the administration of inhaled corticosteroids as indicated in the patient information leaflet for Seretide Accuhaler or Advair® Diskus®.
- •4. Patients who have a QTc of > 500 msec.
- •5. Patients who have a history of relevant drug hypersensitivity.
- •6. Patients who have a history of alcoholism.
- •7. Patients who have a history of drug abuse.
- •8. Patients receiving oral or parenteral corticosteroid treatment within 4 weeks of
- •Randomization for exacerbation of their asthma or who have been intubated for
- •ventilation in the past 5 years or are considered to have very severe asthma.
- •9. Patients who are currently taking inhibitors of CYP3A4 such as ketoconazole,
- •ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir,
- •saquinavir, or telethromycin.
- •10. Patients who consume more than 28 units (male)/ 21 units (female) of alcohol a week.unit = 1 (125 mL) glass of wine = 1 measure of spirits = ½ pint of beer
- •11. Patients who have a significant infection or known inflammatory process on
- •12. Patients who have acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
- •13. Patients who have an acute respiratory infection such as influenza at the time of
- •screening and/or admission.
- •14. Female patients who are pregnant, trying to become pregnant, breast feeding, or not using an acceptable method of contraception.
- •15. Patients who have used any investigational drug in any clinical trial within 3 months of receiving the last dose.
- •16. Patients who have received the last dose of IMP greater than 3 months ago but who are on extended follow-up requiring blood sampling.
- •17. Patients using medication, which in the opinion of the Investigator will affect the
- •outcome of the study.
- •18. Patients who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis).
- •19. Patients who cannot communicate reliably with the investigator.
- •20. Patients who are unlikely to co-operate with the requirements of the study.
研究者
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