EUCTR2004-001075-20-LT进行中（未招募）不适用
A MULTICENTER, RANDOMIZED, DOUBLE BLIND, DOUBLE-DUMMY PLACEBO- CONTROLLED PARALLEL-GROUP MULTIPLE DOSE STUDY OF THE EFFICACY AND SAFETY OF TACROLIMUS INHALATION AEROSOL IN PATIENTS WITH MODERATE PERSISTENT ASTHMA - Tacrolimus MDI Dose Response
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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)Male or female patients between 18 and 70 years of age
- •2)Patients must have a diagnosis of moderate persistent asthma for at least 6 months
- •3)Steroid naïve patients or patients without steroids for at least 6 weeks prior to study entry must have an FEV1 60 - 80 % of the predicted value
- •4)Patients must have a reversibility of greater than 15 % and at least a 0.200 liter increase in their FEV1 within 15 to 30 minutes of receiving two puffs of a short acting ß2-agonist at the screening visit
- •5)Patients must use a short acting ß2-agonist more than two times per day for at least four days per week due to asthma symptoms
- •6)Female patient of child bearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study.
- •7)Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study.
- •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)Inhaled, oral or topical corticosteroids within six weeks prior to study entry
- •2)Respiratory infections within 2 weeks prior to study entry
- •3)History of tuberculosis
- •4)Hospitalization (> 24 hours) for an asthma exacerbation within 90 days prior to study entry or has ever been intubated for an asthma exacerbation
- •5)Moderate to severe liver disease as defined by one or more of the following at Screening:
- •-Aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times the upper limit of normal range
- •-Alkaline phosphatase > 3 times the ULN
- •6)Creatinine > 1.5 times the ULN
- •7)Hemoglobin < 9.0 mg/dl, WBC < 3000 cells/mm3 or a platelet count < 100.000/mm3
- •8)Intake of a long-acting ß2-agonist (e.g. salmeterol or formoterol) within 48 hours prior to study entry
- •9)Patient currently smokes or has discontinued smoking within 6 months prior to the study entry or has a smoking history of = 10 pack years *)
- •10)Patient has used leukotriene modifiers within 2 weeks prior to study entry
- •11)Patient has used monoclonal antibodies for the treatment of asthma, methotrexate, gold salts, cyclosporine, tacrolimus (topical or systemic) or azathioprine within 3 months prior to study entry
- •12)Patient has a decompensated heart failure (NYHA class III and IV)
- •13)Patient is receiving beta-receptor blocking drugs (including eye-drops)
- •14)Patient is taking any prohibited concomitant medication (see section 7.3)
- •15)Patient is known to be HIV positive
- •16)Patient is pregnant or breast-feeding
- •17)Female patient capable of childbearing without effective contraception
- •18)Patient is unlikely to comply with the visits scheduled in the protocol
- •19)Patient is participating or has participated in another investigational drug trial or is receiving or has received an investigational drug within the last 30 days before entry into this study
- •20)Patient has a known hypersensitivity to the active substances or the excipients of the study medication
- •*): Definition of one pack year: Smoking of 20 cigarettes daily for one year or 10 cigarettes daily for two years etc
研究者
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