EUCTR2006-007073-75-DE进行中（未招募）不适用
Randomised, double-blind, double-dummy, parallel trial comparing a novel DPI with 250 µg fluticasone versus Flutide® 250 Diskus® in patients with persistent asthma - Inhalation study fluticasone DPI
mibe GmbH Arzneimittel0 个研究点开始时间: 2007年12月7日最近更新:
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
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. Men or women aged between 18 and 65 years
- •2. Written informed consent
- •3. Current diagnosis of persistent asthma according to generally acknowledged criteria
- •4. For the period of 4 weeks prior to screening: No intake of inhaled corticosteroids or daily regimen of inhaled corticosteroids in a low daily dose of 200 to 400 µg budesonide or equivalent*
- •5. A forced expiratory volume in one second (FEV1) of less than 80% of the predicted value or personal best (if known)
- •6. Need for retriever/ rescue treatment at least twice/ week or occurrence of day-time asthmatic symptoms more than twice/ week
- •7. Documented FEV1-reversibility of equal to or more than 12% (or equal to or more than 200 ml) from the pre-bronchodilator value
- •8. Capable of understanding the directions for device usage
- •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. Respiratory tract infection equal to or less than 6 weeks prior to study entry
- •2. Acute asthma attack, which led to hospitalisation equal to or less than 1 month prior to study entry
- •3. Smokers equal to or less than 6 weeks prior to study entry
- •4. History of cystic fibrosis or bronchiectasis
- •5. Known hypersensitivity to fluticasone propionate or lactose
- •6. Need of more than 8 puffs of 200 µg salbutamol on a daily base
- •7. Previous treatment with oral, parenteral or depot corticosteroids equal to or less than 1 month prior to study entry
- •8. Daily regimen of inhaled long-acting beta-agonists (LABA) like formoterol or salmeterol equal to or less than 4 weeks prior to study entry
- •9. Previous treatment equal to or less than 1 month prior to study entry or concomitant treatment with substances which may decrease the efficacy of the test substance(s) or may lead to drug interactions, as for example strong inhibitors of the cytochrome 450 3A system like ketoconazole, ritonavir or erythromycine
- •10. Clinically significant conditions that might compromise patient safety, patient compliance, interfere with evaluations or preclude completion of the trial, like diabetes mellitus or hyperthyroidism, not adequately controlled
- •11. Severe cardiovascular, hepatic or renal disorders
- •12. Abnormal 12-lead ECG at screening recorded after at least 5 min of rest in supine position
- •13. Acute and/ or serious diseases (e.g. existing malignancy, known HIV-infection, untreated infections)
- •14. Women of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide
- •15. Pregnancy or lactation
- •16. History of alcohol and/or drug and/or substance abuse
- •17. Unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period
- •18. Current participation in another clinical study or former participation in this study
研究者
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