EUCTR2007-001713-42-SE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, parallel group, dose ranging study evaluating the efficacy and safety of GW642444M administered once daily compared with placebo for 28 days in adolescent and adult subjects with persistent asthma.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1 Aged 12 years of age or older at Visit 1
- •For sites in the following countries, subjects recruited will be = 18 years of age:
- •Germany, Hungary and the Russian Federation and any other countries where local
- •regulations or the regulatory status of study medication permit enrolment of adults
- •2 Male or eligible female subjects
- •A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant), including any female who is post-menopausal. Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow-up contact):
- •Complete abstinence from intercourse from screening until 2 weeks after the
- •follow-up contact; or
- •Sterilisation of male partner (vasectomy with documentation of azoospermia)
- •prior to female subject entry into the study, and this male partner is the sole
- •partner for that subject; or
- •Implants of levonorgestral inserted for at least 1 month prior to the study
- •medication administration but not beyond the third successive year following
- •insertion; or
- •Injectable progestogen administered for at least 1 month prior to study
- •medication administration and administered for 1 month following study
- •completion; or
- •Oral contraceptive (combined or progestogen only) administered for at least one
- •monthly cycle prior to study medication administration; or
- •Double barrier method: condom or occlusive cap (diaphragm or cervical/vault
- •caps) plus spermicidal agent (foam/gel/film/cream/suppository)
- •N.B. For German sites female subjects must use a method of birth control other
- •than the double barrier method
- •An intrauterine device (IUD), inserted by a qualified physician, with published
- •data showing that the highest expected failure rate is less than 1% per year; or
- •Estrogenic vaginal ring inserted for at least 1 month prior to study medication
- •administration; or
- •Percutaneous contraceptive patches in place for at least 1 month prior to study
- •medication administration
- •Female subjects should not be enrolled if they are pregnant, or lactating, or plan to
- •become pregnant during the time of study participation.
- •3 Documented clinical history of persistent asthma, as defined by the National
- •Institutes of Health [NIH, 2007] first diagnosed at least 6 months prior to Visit 1.
- •4 Subjects with current reversible airways disease as demonstrated at Visit 1 by an
- •increase in FEV1 of = 12% and = 200ml over the pre-salbutamol/albuterol FEV1 at
- •approximately 30 minutes after the inhalation of 400mcg of salbutamol/albuterol via
- •MDI (spacer permitted for reversibility testing only if required) or one nebulised
- •salbutamol/albuterol solution.
- •5 Subjects must be using an inhaled corticosteroid and have been maintained on a
- •stable dose for 4 weeks prior to Visit 1 at one of the following doses:
- •Maximum Allowable Concurrent Inhaled Corticosteroid Doses
- •Asthma Therapy Maximum Daily Dose (mcg/day)
- •fluticasone propionate MDI CFC/HFA = 880mcg(1)/ =1000mcg(2)
- •fluticasone propionate DPI = 1000mcg
- •beclomethasone dipropionate = 1680mcg(1)/ = 2000mcg(2)
- •beclomethasone dipropionate HFA (QVAR) = 640mcg(1)/ = 800mcg(2)
- •budesonide DPI/MDI = 2000mcg
排除标准
- •1 Culture-documented or suspected bacterial or viral infection of the upper or lower
- •respiratory tract, sinus or middle ear and/or exacerbation of asthma within 4 weeks
- •of Visit 1.
- •2 History of life-threatening asthma, defined as an asthma episode that required
- •intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia
- •3 Asthma exacerbation requiring treatment with oral corticosteroids within 3 months
- •prior to Visit 1.
- •4 Hospitalised for an asthma exacerbation within 6 months of Visit 1.
- •Hospitalisation is defined as an overnight stay in a hospital.
- •5 Previously enrolled in this study, or has participated in any study using an
- •investigational drug during the previous 30 days or will participate simultaneously in
- •another clinical trial.
- •6 A subject must not have any clinically significant, uncontrolled condition or disease
- •state that, in the opinion of the investigator, would put the subject's safety at risk
- •through study participation or would confound the interpretation of the efficacy
- •results if the condition/disease exacerbated during the study.
- •The list of additional excluded conditions/diseases includes, but is not limited to the
- •following:Please see section 4.3.6 of the exclusion criteria within protocol.
- •7 Any adverse reaction including immediate or delayed hypersensitivity to any
- •ß2-agonist or sympathomimetic drug, or known or suspected sensitivity to the
- •constituents of GW642444M inhalation powder (i.e. lactose or magnesium stearate).
- •8 Subjects who are likely to be non-compliant with study medication and other studyrelated
- •requirements (e.g. attendance at clinic visits or completion of Daily Diary).
- •9 Neurological or psychiatric disease or history of drug or alcohol abuse which would
- •interfere with the subject’s proper completion of the protocol requirements.
- •Abuse of alcohol is defined as an average weekly intake of greater than 21 units or
- •an average daily intake of greater than 3 units (males) or defined as an average
- •weekly intake of greater than 14 units or an average daily intake of greater than 2
- •units (females). The number of units of alcohol in a drink can be determined by
- •multiplying the volume of the drink (in millilitres) by its percentage ABV and
- •dividing by 1000
- •10 Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day
- •for 10 years). A subject may not have used tobacco products within the past one
- •year (i.e., cigarettes, cigars, or pipe tobacco).
- •11 Administration of systemic, oral or depot corticosteroids or administration of
- •anti-IgE (e.g. omalizumab [Xolair]) within 12 weeks of Visit 1.
- •12 Administration of any of the following asthma medications within 14 days of Visit 1: Please see section 4.3.12 of the exclusion within the protocol.
- •13 Administration of inhaled long-acting ß2-agonists (e.g. salmeterol) within 7 days of
- •14 Administration of any other prescription or over the counter medication which may
- •affect the course of asthma, or interact with sympathomimetic amines, such as:
- •Anticonvulsants (barbiturates, hydantoins, and carbamazepine); Polycyclic
- •antidepressants; ß-adrenergic blocking agents; Phenothiazines and Monoamine
- •oxidase (MAO) inhibitors
- •15 Administration of a potent P-glycoprotein inhibitor or potent Cytochrome P450 3A4
- •inhibitor within 4 weeks prior to Visit 1 (e.g. ritonavir and ketoconazole)
- •16 A subject will not be eligible for this study if he/she is an immediate family member
- •of the participating Investigator, sub-I
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