EUCTR2009-018006-21-EE进行中（未招募）不适用
A Phase II, randomised, double- blind, placebo controlled, cross-overefficacy and safety comparison of tiotropium 5 µg administered oncedaily (in the evening) and tiotropium 2.5 µg administered twice dailydelivered by the Respimat® inhaler for four weeks versus placebo inpatients with moderate persistent asthma
Boehringer Ingelheim RCV GmbH & CoKG0 个研究点目标入组 90 人开始时间: 2010年6月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •Outpatients with a history of asthma and a current diagnosis of moderate persistent asthma (according to GINA guideline) are eligible for inclusion if they fulfil all the inclusion criteria and none of the exclusion criteria.
- •1. All patients must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1).
- •2. Male or female patients aged at least 18 years but not more than 75 years.
- •3. All patients must have at least a 3 months history of asthma at the time of enrolment into the trial. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15 minutes after 400 µg salbutamol) resulting in a FEV1 increase of = 12% and = 200mL.
- •4. The initial diagnosis of asthma must have been made before the patient's age of 40.
- •5. All patients must have a diagnosis of moderate persistent asthma and must be
- •symptomatic despite their current maintenance treatment with medium doses of inhaled corticosteroids.
- •6. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids (alone or in a fixed combination with a
- •LABA or SABA) for at least 4 weeks prior to Visit 1.
- •7. All patients must be symptomatic at Visit 1 (screening) and Visit 2 as defined by an
- •ACQ (see Appendix 10.4) mean score of = 1.5.
- •NOTE: If the patient is not eligible due to the predefined score at Visit 1, the patient
- •should not be further evaluated. If the patient is not eligible due to the predefined score atVisit 2, the patient’s Visit 2 can be repeated once for further assessment
- •8. All patients must have a pre-bronchodilator FEV1 = 60% predicted and = 90% of
- •predicted normal at Visit 1.
- •Predicted normal values will be calculated according to ECSC [R94-1408].
- •9. All patients must have an increase in FEV1 of = 12% and = 200 mL 15 minutes after 400 µg salbutamol at Visit 1. NOTE: If this is not achieved the reversibility test may be repeated once within two weeks.
- •10. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
- •11. Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years.
- •12. Patients must be able to use the Respimat® inhaler (Appendix 10.1) correctly.
- •13. Patients must be able to perform all trial related procedures including technically
- •acceptable pulmonary function tests and use of the e-Diary/peak flow meter (e-Diarycompliance of at least 80% is required; refer to Section 6.2.1 for instructions).
- •14. Patients taking a chronic pulmonary medication allowed by the study protocol must be willing to continue this therapy for the entire duration of the study (exception: times of acute disease deterioration).
- •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. Patients with a significant disease other than asthma.
- •A significant disease is defined as a disease which, in the opinion of the investigator,
- •may (i) put the patient at risk because of participation in the trial, or (ii) influence the
- •results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
- •2. Patients with a clinically relevant abnormal screening hematology or blood chemistry if the abnormalitiy defines a significant disease as defined in exclusion criterion no. 1.
- •3. Patients with a recent history (i.e. six months or less) of myocardial infarction.
- •4. Patients who have been hospitalised for cardiac failure during the past year.
- •5. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia
- •requiring intervention or a change in drug therapy within the past year.
- •6. Patients with lung diseases other than asthma (e.g. COPD).
- •7. Patients with known active tuberculosis.
- •8. Patients with malignancy for which the patient has undergone resection, radiation
- •therapy or chemotherapy within the last five years. Patients with treated basal cell
- •carcinoma are allowed.
- •9. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 1.
- •10. Patients with significant alcohol or drug abuse within the past two years.
- •11. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening).
- •12. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the study medication delivery systems.
- •13. Pregnant or nursing women.
- •14. Women of childbearing potential not using a highly effective method of birth control.
- •Highly effective methods of birth control are defined as those which result in a low
- •failure rate (i.e. less than 1% per year) when used consistently and correctly such as
- •implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner. Barrier methods of contraception are accepted if condom or occlusive cap are used together with spermicides (e.g. foam, gel). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.
- •15. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 or during the screening period. Topical cardio-selective beta-blocker eye medications for non-arrow angle glaucoma are allowed.
- •16. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 or during the screening period.
- •17. Patients who have been treated with oral beta-adrenergics within four weeks prior to Visit 1 or during the screening period.
- •18. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 or during the screening period.
- •19. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 or during the screening period.
- •20. Patients who have been treated with cromolyn sodium or nedocromil sodium within two weeks prior to Visit 1 or during the screening period.
- •21. Patients who have been treated with methylxanthines within two weeks prior to Visit 1 or d
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