EUCTR2004-002079-18-HU进行中（未招募）不适用
A MULTICENTRE, RANDOMISED, DOUBLE BLIND, DOUBLE-DUMMY PARALLEL-GROUP STUDY INVESTIGATING THE EFFICACY AND SAFETY OF THREE DIFFERENT DOSES OF TACROLIMUS INHALATION AEROSOL AND A STANDARD DOSE OF INHALED CORTICOSTEROID (ICS) IN PATIENTS WITH MODERATE PERSISTENT ASTHMA - Tacrolimus MDI versus ICS
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
- 360
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 the Run-in period
- •1) Male or female patients between 18 and 70 years of age inclusive
- •2) Patients must have a diagnosis of asthma for at least 6 months
- •3) Patients must have been pre-treated with inhaled corticosteroids (daily ICS
- •dose of up to 800 mcg budesonide, 500 mcg fluticasone, 1000 mcg beclomethasone or 400 mcg beclomethasone extra-fine aerosol) for at least 6 months prior to study entry.
- •4) Patients must use a short acting ß2-agonist more than twice a day for at least four days per week due to asthma symptoms
- •5) Patients must have an FEV1 = 60 to 80 % of the predicted value
- •6) Patients must have a reversibility of at least 15 % and at least a 200ml increase in their FEV1 within 30 minutes of receiving two puffs of a short acting ß2-agonist (salbutamol) at the screening visit
- •7) Patients on immunotherapy must have been on a stable dose for one month prior to study entry and remain on that stable dose during the conduct of the study
- •8) 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.
- •9) 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.
- •Inclusion Criterion for randomisation
- •1) FEV1 at baseline does not differ more than 15 % from the value obtained at
- •the screening visit and FEV1 is still = 80% of the predicted.
- •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) Systemic/oral corticosteroids within six weeks prior to study entry
- •2) Respiratory infections within 2 weeks prior to study entry
- •3) History of tuberculosis
- •4) Hospitalisation (> 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
- •-Aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times the
- •upper limit of normal (ULN)
- •-Alkaline phosphatase > 3 times the ULN
- •6) Creatinine > 1.5 times the ULN
- •7) Haemoglobin < 9.0 g/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 24 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 a history of alcohol abuse within the last 5 years
- •11) Patient has used leukotriene modifiers within 4 weeks prior to study entry
- •12) 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
- •13) Patient is receiving beta-receptor blocking drugs (including eye-drops)
- •14) Patient is receiving any prohibited concomitant medication
- •15) Patient has an advanced, severe or unstable disease of any type other than
- •moderate asthma (e.g. advanced chronic heart failure NYHA class III or IV, arrhythmia, subvalvular aortic stenosis, severe hypertension, aneurysm, ischemic heart disease, AV block III, uncontrolled diabetes mellitus)
- •16) Patient has a haematologic or solid malignancy diagnosed within five years
- •prior to study entry. (Note: Patient with localized skin cancer, i.e. basal cell or
- •squamous cell carcinoma, may participate in the study. Patient who has
- •received adequate treatment for localized cancer may be allowed to participate
- •in the study subject to approval by the Medical Monitor.)
- •17) Patient has any significant concomitant disease in the opinion of the investigator
- •18) Patient is known to be HIV positive
- •19) Patient is pregnant or a breast-feeding mother
- •20) Patient is unlikely to comply with the visits scheduled in the protocol.
- •21) Patient is participating or has participated in another investigational drug trial or
- •is receiving or has received an investigational drug within the last 28 days before entry into this study
- •22) Patient has a known hypersensitivity to macrolides, the active substances or the
- •excipients of the study medication
- •23) Patient has been previously enrolled in this study
- •*Definition of one pack year: Smoking of 20 cigarettes daily for one year or 10
- •cigarettes daily for two years etc.
研究者
相似试验
进行中（未招募）
不适用
A MULTICENTRE, RANDOMISED, DOUBLE BLIND, DOUBLE-DUMMY PARALLEL-GROUP STUDY INVESTIGATING THE EFFICACY AND SAFETY OF THREE DIFFERENT DOSES OF TACROLIMUS INHALATION AEROSOL AND A STANDARD DOSE OF INHALED CORTICOSTEROID (ICS) IN PATIENTS WITH MODERATE PERSISTENT ASTHMA - Tacrolimus MDI versus ICSAsthmaEUCTR2004-002079-18-CZFujisawa GmbH360
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 ResponseModerate persistent asthmaMedDRA version: 7.0Level: LLTClassification code 10003555EUCTR2004-001075-20-LTFujisawa GmbH400
进行中（未招募）
不适用
A MULTICENTRE, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PARALLEL-GROUP STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE BETWEEN FLUTICASONEPROPIONATE, 100 µg TWICE DAILY DELIVERED VIA A PRESSURISED METERED DOSE INHALER (MERCK GENERICS) WITH A REFERENCE FLUTICASONE PROPIONATEFORMULATION, 100 µg TWICE DAILY ADMINISTERED FROM A REFERENCE PRESSURISED METERED DOSE INHALER IN INHALED CORTICOSTEROID NAÏVE PAEDIATRIC PATIENTS WITH MILD TO MODERATE PERSISTENT ASTHMA (APOLLO STUDY) - APOLLOAsthmaMedDRA version: 8.1Level: LLTClassification code 10003555EUCTR2005-006077-27-HUMerck Generics608
进行中（未招募）
不适用
A MULTICENTRE, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PARALLEL-GROUP STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE BETWEEN FLUTICASONEPROPIONATE, 100 µg TWICE DAILY DELIVERED VIA A PRESSURISED METERED DOSE INHALER (MERCK GENERICS) WITH A REFERENCE FLUTICASONE PROPIONATEFORMULATION, 100 µg TWICE DAILY ADMINISTERED FROM A REFERENCE PRESSURISED METERED DOSE INHALER IN INHALED CORTICOSTEROID NAÏVE PAEDIATRIC PATIENTS WITH MILD TO MODERATE PERSISTENT ASTHMA (APOLLO STUDY) - APOLLOMedDRA version: 8.1Level: LLTClassification code 10003555AsthmaEUCTR2005-006077-27-CZMerck Generics608
进行中（未招募）
不适用
A MULTICENTRE, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PARALLEL-GROUP STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE BETWEEN FLUTICASONEPROPIONATE, 100 µg TWICE DAILY DELIVERED VIA A PRESSURISED METERED DOSE INHALER (MERCK GENERICS) WITH A REFERENCE FLUTICASONE PROPIONATEFORMULATION, 100 µg TWICE DAILY ADMINISTERED FROM A REFERENCE PRESSURISED METERED DOSE INHALER IN INHALED CORTICOSTEROID NAÏVE PAEDIATRIC PATIENTS WITH MILD TO MODERATE PERSISTENT ASTHMA (APOLLO STUDY) - APOLLOMedDRA version: 8.1Level: LLTClassification code 10003555AsthmaEUCTR2005-006077-27-DEMerck Generics608