EUCTR2006-005998-21-FR进行中（未招募）1 期
A multicentre randomised, double-blind, parallel-group study to compare the salmeterol xinafoate/fluticasone propionate combination (Seretide® Diskus® 50/100) 50/100 micrograms one inhalation twice daily with fluticasone propionate (Flixotide® Diskus® 100) 100 micrograms one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma.
aboratoire GlaxoSmithKline0 个研究点目标入组 0 人开始时间: 2007年1月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Inclusion criteria for entry into the run-in period
- •1- Male or female adult aged =18 years
- •2- A documented clinical history of asthma
- •3- A documented diagnosis of asthma on lung function based on airway reversibility of =12% in the last 2 years or at visit 1 based on either FEV1 or PEF measured pre and post inhalation of 400µg salbutamol (possible to demonstrate at Visit 2 for subjects who failed to demonstrate at Visit 1)
- •4- A diagnosis of moderate persistent asthma defined as
- •- daily symptoms
- •- daily rescue use
- •5- Inhaled corticosteroid-naive or inhaled corticosteroid-free (i.e.; no inhaled corticosteroids for at least 12 weeks prior to Visit 1)
- •6- Able to use the Mini-Wright peak flow meter
- •7- Able to complete a DRC
- •8- Able to use a Diskus® correctly
- •9- Affiliated or a beneficiary of a social security category
- •10- A female is eligible to enter and participate in the study if she is:
- •a- of a non-child-bearing potential OR
- •b- of child bearing potential but has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study
- •Inclusion criteria for entry into the treatment period
- •1- A diagnosis of moderate persistent asthma based on the DRC and defined as
- •- daily syptoms
- •- daily rescue use
- •- and moderate to severe airflow limitation based on mean morning PEF between 60-80% predicted measured over the last 7 days of the run-in period on the DRC values
- •2- Demonstrated reversibility = 12% based on FEV1 or PEF measured pre and post-inhalation of 400 µg salbutamol for subjects who failed to demonstrate at Visit 1
- •3- A subject must have completed 80% of assessments on the DRC the last 7 days of the run-in period
- •4- For patients participating to the CT-scan sub-sudy only: if subject is of child bearing potential, a negative pregnancy urine test must be obtained.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for entry into the run-in period
- •1-Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
- •2- FEV1< 60% predicted
- •3- Subjects who have participated in any study using an investigational drug during the previous 4 weeks prior to Visit 1
- •4- Subjects who have an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to Visit 1
- •5- Acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalization within 12 weeks of Visit 1 or at Visit 1
- •6- Use of oral parenteral or depot corticosteroid within 6 months of Visit 1
- •7- Use of long-acting inhaled beta2-agonist or oral beta2-agonist within 4 weeks of Visit 1
- •8- Use of Anti-leucotrienes, including suppressors of leukotriene production and leukotriene antagonists or theophyllines within 4 weeks of Visit 1
- •9- Known clinical or laboratory envidence of a serious uncontrolled disease (including serious psychological disorders) likely to interfere with the study
- •10- Subjects with a known or suspected hypersensitivity to inhaled corticosteroids, beta2-agonists, or any components of the formulations (e.g. lactose)
- •11- Subjects who use any medication that significantly inhibits the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketokonazole
- •12- Sujects who have previously been randomised in this study
- •13- Smoking history: smoker and former smoker subjects who have more than 5 pack years
- •14- Subjet who is pregnant or lactating; Subjects should not be enrolled if they plan to become pregnant during the time of study participation (up to visit 5).
- •Exclusion criteria for entry into the CT scan study
- •1- For CT scan population only: Patients aged > 40 years
- •2- For CT scan population only: current smoker or former smoker who has stopped smoking within the 6 months before visit 1
- •Exclusion criteria for entry into the treatment period
- •1- Change in asthma medication(excluding study rescue medication)
- •2- Respiratory tract infection or exacerbation of asthma
- •3- Use of oral, parenteral or depot corticosteroids
- •4- Non-compliance with the completion of the DRC during the run-in
- •5- Subject who is pregant or lactating. Subjects should not be enrolled if they plan to become pregnant during the time of study participation (up to visit 5).
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