EUCTR2006-004979-35-HU进行中（未招募）不适用
A RANDOMISED, FOUR WAY CROSS-OVER STUDY TO ASSESS BRONCHODILATION, SAFETY AND TOLERABILITY OF NEW GENERIC DRY POWDER FORMOTEROL FORMULATIONS GIVEN AS CUMULATIVE DOSES FROM A NOVEL DRY POWDER INHALER AND TWO REFERENCE DRY POWDER FORMULATIONS IN ADULT ASTHMATIC PATIENTS
Andi - Ventis0 个研究点目标入组 16 人开始时间: 2006年9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
- 16
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
- •At study entry:
- •1. Male and female asthmatic patients, aged 18 - 55 years inclusive.
- •2. Documented asthma for at least 6 months before screening.
- •3. Subjects with a FEV1 > 50% of the predicted normal value for age, height and gender after withholding short acting b2-agonists for at least 6 hours and long acting b2- agonists for at least 24 hours.
- •4. Subjects who demonstrate a reversibility of > 12.00% (of the predicted value) in FEV1 10 minutes after a dose of 12mg formoterol from the Aerolizer.
- •5. Subjects who are able to handle dry powder inhalers correctly.
- •6. Subjects who are able to perform lung function tests properly.
- •7. Subjects who are willing to give written informed consent to participate in the study.
- •On study days:
- •1. A pre-dose baseline FEV1 within 10% of the value obtained at the Screening Visit.
- •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 currently receiving oral corticosteroid therapy or who have received oral
- •corticosteroid therapy in the 3 months preceding the screening.
- •2. Patients currently receiving therapy for an upper respiratory tract infection or who have received such a therapy in the month prior to the start of the study.
- •3. Patients who have been hospitalised or received emergency treatment for an exacerbation of asthma in the 3 months prior to the start of the study.
- •4. Patients with a known or suspected hypersensitivity to formoterol or its recipients.
- •5. Patients who are unable to perform lung function tests.
- •6. Patients with any of the following concurrent conditions:
- •· Uncontrolled diabetes mellitus
- •· Evidence of current neoplastic disease other than basal cell carcinoma
- •· Evidence of tuberculosis
- •· Evidence of significant cardiovascular disease
- •· Respiratory disorders other than asthma or rhinitis
- •· Significant hepatic or renal insufficiency.
- •· Evidence or history of alcohol or drug abuse.
- •· Evidence or history of low potassium levels or concomitant use of non-potassium
- •sparing diuretics
- •· Use of Mono-Amine-Oxydase inhibitors or tricyclic antidepressants.
- •· Use of Leukotriene-antagonists, either currently or during the last week preceding the screening visit.
- •· Use of non-selective beta-receptor blocking agents like beta-blocking antihypertensive products.
- •7. Patients currently receiving other investigational medication or who have received
- •investigational medication in the month prior to the screening of the study.
- •8. Employees of the Sponsor or the CRO responsible for the execution of the study.
- •9. Women who are pregnant, lactating or likely to become pregnant during the course of the study. Women of child bearing potential will be eligible to enter the study if using adequate contraception (i.e. contraceptive pill or barrier methods).
- •On study days:
- •1. A pre-dose baseline FEV1 outside 10.00% of the value obtained at the Screening Visit.
- •2. Use of short-acting b2 agonists in the 6 hours preceding this visit or long-acting b2
- •agonists in the 24 hours preceding this visit.
- •3. Any clinically significant abnormality following the investigator’s review of the clinical laboratory test done at the previous visit.
研究者
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