EUCTR2006-000334-12-DE进行中（未招募）1 期
A RANDOMIZED, PLACEBO CONTROLLED, DOUBLE-BLIND, CROSS-OVER, MONOCENTER STUDY TO EVALUATE THE EFFECT OF A 7-DAY MONTELUKAST TREATMENT ON AIRWAY INFLAMMATION AND FUNCTION BY MEANS OF BRONCHOPROVOCATION WITH ADENOSINE-5’-MONOPHOSPHATE IN PATIENTS WITH MILD OR MODERATE ALLERGIC ASTHMA - M/MTAST/01
Almirall Prodesfarma0 个研究点目标入组 18 人开始时间: 2006年8月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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.Eighteen to seventy years old male or female patients having been diagnosed of mild or moderate allergic asthma for at least 6 months.
- •2.Atopy as indicated by at least one positive skin prick test to one or more common aeroallergens within the last preceding 12 months.
- •3.Patients must have not been treated with long-acting ß2 agonist within the last 48 hours or corticosteroids within 6 weeks prior to study entry.
- •4.FEV1 = 70% of predicted at screening.
- •5.PC20 AMP = 400 mg/ml at screening.
- •6.No smoking history during the last 12 months and no history of smoking more than 10 packs/year (definition: smoking history of 20 cigarettes daily for one year or of 10 cigarettes daily for 2 years etc.).
- •7.No concurrent treatment, except Salbutamol, may be planned during protocol treatment.
- •8.Normal organ and marrow function as defined at the discretion of the investigator.
- •9.Negative pregnancy test in women of reproductive potential.
- •10.Women of reproductive potential must agree to use adequate contraception prior to study entry and during the trial.
- •11.Ability to communicate adequately with investigators and comply with the requirements of the entire study.
- •12.Ability to understand and the willingness to sign an informed consent document.
- •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
- •1.Intubation (ever) or hospitalization for longer than 24 hours within the preceding six weeks for the management of an asthma exacerbation.
- •2.Asthma exacerbation within 6 weeks prior to study entry.
- •3.Long-acting ß2 agonist within the last 48 hours or corticosteroids within 6 weeks prior to study entry.
- •4.Respiratory infection within 2 preceding weeks of study entry.
- •5.Current use of ß antagonist.
- •6.Use of monoclonal antibodies for the treatment of asthma, methotrexate, gold salts, cyclosporine, tacrolimus (topical or systemic), or azathioprine within 3 months prior to study entry.
- •7.Participation in another investigational drug trial within the preceding 30 days of study entry.
- •8.History of alcohol or drug abuse.
- •9.Pregnancy or nursing.
- •10.HIV seropositivity.
- •11.Known hypersensitivity against Montelukast-Natrium or any other active ingredient (cellulose, lactose-monohydrate, Hypromellose, Hyprolose, Magnesiumstarate, Titandioxide, Ferrum-III-oxide (E172), Ferrumoxidehydrate (E 172), Carnaubawax).
- •12.Severe dysfunction of the liver.
- •13.Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •14.Use of Phenobarbital, Phenytoin, Rifampicin.
- •15.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic intracranial disease, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •16.History of severe neurological, cardiovascular, renal, hepatic, respiratory, bone marrow dysfunction, organ graft or autoimmune disease (treated or not).
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