EUCTR2008-001027-59-GB进行中（未招募）不适用
A Randomised, Double-Blind, Double-Dummy Cross-Over Study to demonstrate Superiority of Fluticasone/ Salmeterol pMDI over double the dose of Fluticasone pMDI on Methacholine Hyper-Reactivity in Patients with Persistent, Mild to Moderate Asthma (as defined by GINA guidelines). - NEO 040/FPSM/pMDI/ChallengeSuperior
niversity of Dundee0 个研究点开始时间: 2008年7月15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. Written informed consent given by patient.
- •2. Male or female patients between 18 and 65 years of age inclusive.
- •3. Persistent stable asthmatics (FEV1 > 60%) on = 1000 µg FP or equivalent or if on combination therapy up to 500 µg of FP or equivalent (e.g. FP/SM 125 2-puffs BD or BUD/FM 200/6 2-puffs BD)
- •4. Patients suffering from stable, persistent, mild to moderate asthma as defined by GINA Guidelines and for whom FEV1 > 60 %
- •5. Methacholine PC20 < 4mg/ml with a doubling dose (2dd) shift in PC20 after 400µg of salbutamol after wash-out (i.e. to identify ß2 responders).
- •6. In the opinion of the investigator, able and willing to comply with the requirements of the protocol.
- •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. Severe asthmatics as defined by an FEV1 < 60% or PEF variability >30% or with continual daytime or nocturnal symptoms.
- •2. Known or suspected hypersensitivity to FP or any other constituents of the Test or Reference pMDI
- •3. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study (such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA / CVA).
- •4. Females who are pregnant, lactating or planning to become pregnant.
- •5. Approximately half of the subjects will be smokers and half currently non-smokers (or who have ceased smoking at least 1 year previously).
- •6. Clinically significant laboratory values, as judged by the investigator.
- •7. Patients who have previously been enrolled into this study.
- •8. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit.
- •9. Patients who are scheduled to receive any other investigational drug during the course of the study.
- •10. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
- •11. Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
- •12. Respiratory tract infection in the previous 2 months.
- •13. Patients with significant concomitant respiratory disease such as COPD, CF, ABPA, active pulmonary TB or bronchiectesis.
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