EUCTR2010-021093-11-SK进行中（未招募）1 期
A Phase III randomised, double blind, placebo-controlled, parallel group study to assess the efficacy and safety over 48 weeks of orally inhaled Tiotropium bromide (2.5 µg and 5 µg once daily ) delivered by the Respimat® inhaler in adolescents (12 to 17 years old) with moderate persistent asthma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 243
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. All patients and their parents (or legally accepted caregiver) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial.
- •2. Male or female patients between 12 and 17 years of age.
- •3. All patients must have at least a 3 months history of asthma at the time of enrolment into the trial.
- •4.All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose.
- •5.All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an ACQ mean score of = 1.5.
- •6. All patients must have a pre-bronchodilator FEV1 =60% and = 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
- •7. All patients must have an increase in FEV1 of = 12% and = 200 mL 15 to 30 minutes after 400 µg salbutamol (albuterol) at Visit 1.
- •8. All patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment.
- •9. Patients should be able to use the Respimat® inhaler correctly.
- •10. Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres, according to ATS/ERS standards and the use of the electronic diary/peak flow meter.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with a significant disease other than asthma.
- •2. Patients with clinically relevant abnormal screening haematology or blood chemistry.
- •3. Patients with a history of congenital or acquired heart disease, and/or have been hospitalised for cardiac syncope or failure during the past year.
- •4.Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
- •5.Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
- •6. Patients with lung diseases other than asthma (e.g. CF). In case of ex-premature infants, a history of significant bronchopulmonary dysplasia will be regarded as exclusion criterion.
- •7. Patients with known active tuberculosis.
- •8. Patients with significant alcohol or drug abuse within the past two years.
- •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 who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
- •11. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution.
- •12. Pregnant or nursing adolescent female patients
- •13. Sexually active female patients of child-bearing potential not using a highly effective method of birth control.
- •14. Patients who have taken an investigational drug within 4 weeks prior to Visit 1.
- •15. Patients who have been treated with long-acting anticholinergics
- •16. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation.
- •17. Patients who have been treated with Anti-IgE treatment within the last 6 months prior to screening.
- •18. Patients who have been treated with systemic (oral or intravenous) corticosteroids within 4 weeks prior to screening (Visit 1).
- •19. Patients who have been treated with long-acting theophylline preparations within 2 weeks prior to screening (Visit 1) or during the run-in period
- •20. Patients who have been treated with other non-approved and according to international guidelines not recommended experimental” drugs for routine asthma therapy .
- •21. Patients with any acute asthma exacerbation or respiratory tract infection in the 4 weeks prior to Visit 1.
- •22. Patients requiring 10 or more puffs of rescue medication (salbutamol/albuterol MDI) per day on more than 2 consecutive days during the run-in period.
- •23. Patients who have previously been randomised in this trial or are currently participating in another study.
- •24. Patients who are being treated with oral beta-blocker medication.
- •25. Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
- •26. Patients with renal impairment.
研究者
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