EUCTR2006-002694-52-GB进行中（未招募）1 期
A comparison of ipratropium bromide/salbutamol delivered by the Respimat inhaler to COMBIVENT Inhalation Aerosol and ipratropium bromide delivered by the Respimat in a 12-week, double-blind, safety and efficacy study in adults with chronic obstructive pulmonary disease - Safety&Efficacy of Comb. Respimat COPD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,440
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
入选标准
- •1. All patients must have a diagnosis of COPD and must meet the following spirometric criteria at Visit 1 (Screening) and Visit 2: Patients must have relatively stable, moderate to severe airway obstruction with pre-bronchodilator FEV1 ?65% of predicted normal and FEV1 ?70% of FVC. Predicted normal values will be calculated according to ECSC [R94-1408]
- •2.Male or female patients 40 years of age or older.
- •3.Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year.
- •4.Patients must be able to perform pulmonary function tests and maintain records during the study period as required in the protocol.
- •5.Patients must be able to be trained in the proper use of an MDI and the Respimat® inhaler.
- •6.All patients must sign an Informed Consent Form prior to participation in the trial
- •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 significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- •2Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded.
- •3.All patients with an AST (SGOT) >80 IU/L, ALT (SGPT) >80 IU/L, Bilirubin >2.0 mg/dL or Creatinine >2.0 mg/dL will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects.
- •4.Patients who have a total blood Eosinophil count =600/mm3. A repeat Eosinophil count will not be conducted in these patients.
- •5.Patients with a recent history (i.e., one year or less) of myocardial infarction.
- •6.Patients with a recent history (i.e., three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
- •7.Patients with a history of cancer, other than treated basal cell or fully cured squamous carcinoma, within the last five years.
- •8.Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
- •9.Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
- •10.Patients with a history of asthma or allergic rhinitis.
- •11.Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion 1.
- •12.Patients with known active tuberculosis.
- •13.Patients with an upper or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period.
- •14.Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
- •15.Patients with known narrow-angle glaucoma.
- •16.Patients with current significant psychiatric disorders.
- •17.Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy.
- •18.Use of cromolyn sodium or nedocromil sodium less than 30 days prior to the baseline period or during the treatment period.
- •19.Patients who are being treated with antihistamines for any excluded allergic conditions.
- •20.Patients using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
- •21.Initiation of inhaled steroid use, or new dosage, less than 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period.
- •22.Use of beta-blocker medications, MAO inhibitors or tricyclic antidepressants less than 30 days prior to the baseline period or during the treatment period . Beta blocker eye medications for treatment of non-narrow angle glaucoma are allowed.
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