EUCTR2008-001413-14-DE进行中（未招募）不适用
A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat ® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma
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
- 300
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. signed and dated Informed Consent Form consistent with ICH-GCP guidelines and local legislation prior to participation in the trial
- •2. Male or female patients aged at least 18 years but not more than 75 years.
- •3. At least a 5-year history of asthma (GINA 2007)
- •4. Diagnosis of asthma before the patient’s age of 40.
- •5. All patients must have a diagnosis of severe persistent asthma and must be symptomatic despite treatment with high, stable doses of inhaled corticosteroids and a long-acting beta adrenergic agent
- •6. All patients must have been on treatment with a high, stable dose of inhaled corticosteroids and a long-acting beta2 adrenergic agent for at least 4 weeks before the screening visit. Additional sustained release theophylline and/or leukotriene modifier and/or omalizumab (Xolair®) and/or oral glucocortico-steroids are allowed in stable doses.
- •7. ACQ mean score of >= 1.5 at screening and randomisation visit
- •8. History of one or more asthma exacerbation in the past year that required an addition or increased dose of systemic corticosteroids.
- •9. Post bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol/albuterol) FEV1 = 80% of predicted normal and FEV1 = 70% of FVC
- •10. Variation of FEV1 at Visit 1 and Visit 2 must be within +/- 30%.
- •11. 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.
- •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. Any significant disease other than asthma which 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. Clinically relevant abnormal screening haematology or blood chemistry if the abnormality defines a significant disease
- •3. Recent history (i.e. six months or less) of myocardial infarction.
- •4. Hospitalisation for cardiac failure during the past year.
- •5. Unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
- •7. Lung diseases other than asthma (e.g. COPD).
- •8. Known active tuberculosis.
- •9. Alcohol or drug abuse within the past two years.
- •10. Past thoracotomy with pulmonary resection.
- •12. Oral corticosteroid medication at stable doses >=5 mg prednisolone
- •13. Known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution.
- •14. Pregnant or nursing women.
- •15. Women of childbearing potential not using a highly effective method of birth control.
- •16. Patients who have taken an investigational drug within four weeks or six half-lives
- •17. Patients who have been treated with tiotropium within four weeks
- •18. Patients who have been treated with beta-blocker medication within four weeks
- •19. Patients who have been treated with oral beta-adrenergics within four weeks
- •20. Patients who have been treated with other non-approved and according to international guidelines not recommended ´experimental´ drugs for routine asthma therapy (e.g. TNF-alpha blockers, methotrexate, cyclosporin) within four weeks
- •21. Any asthma exacerbation in the four weeks prior
- •22. Any respiratory tract infection in the four weeks prior
- •23. Patients who have previously been randomised in this trial or in the respective twin trial or are currently participating in another trial.
- •24. Known narrow-angle glaucoma
- •25. People who are serving a custodial sentence, or who are detained under local mental health legislation/regulations (local for Germany)
研究者
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