EUCTR2006-001975-40-IE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effects of a 4-week treatment of 30 mg b.i.d BIBW 2948 BS (inhalation powder, hard capsule for HandiHaler®) on epithelial mucin stores and the safety and efficacy in COPD patients with symptoms associated with chronic bronchitis - Effects of BIBW 2948 on epithelial mucin
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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 must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication restrictions.
- •2. All patients must have a diagnosis of COPD.
- •3. Patients must have post-bronchodilator forced expiratory volume in 1 second/forced vital capacity FEV1/FVC <70% and FEV1 = 40% predicted. (See Appendix 5 for predicted normal values.)
- •4. Patients should have symptoms associated with chronic bronchitis and must have symptoms of cough and sputum production on most days during at least 3 months for 2 consecutive years.
- •5. Male and females between the ages of 40 and 70 years
- •6. Patients who are actively smoking at least 10 cigarettes a day, have a smoking history of 10-pack years or more.
- •7. Patients must be able to read and understand the questionnaires in the languages provided (English in the U.S. and Ireland, German in Germany).
- •8. Patients must be able to perform technically acceptable pulmonary function tests, undergo bronchoscopy, and all associated study procedures in the opinion of the investigator.
- •9. Patients must be able to inhale medication in a competent manner from the HandiHaler device for BIBW 2948 BS.
- •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 or chronic bronchitis are excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject’s ability to participate in the study.
- •2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis if the abnormality defines a significant disease as defined in exclusion criteria No. 1.
- •3. All patients with a serum glutamate oxaloactetate transferase (SGOT) >80 IU/L, 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 patients.
- •4. Patients with a history of thoracotomy with pulmonary resection.
- •5. Patients with known active tuberculosis.
- •6. Patients with current significant psychiatric disorders.
- •7. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
- •8. Patients with history of asthma or allergic rhinitis.
- •9. Patients with a history of sinusitis within the last 3 months.
- •10. Patients with a significant history of alcohol or drug abuse or current significant use of these substances based on the investigators judgement.
- •11. Use of oral or inhaled corticosteroids in the 4 weeks prior to screening or during the baseline or treatment periods.
- •12. Patients who are being treated with cromolyn sodium or nedocromil sodium.
- •13. Patients with a dependence of supplementary oxygen for activities of daily living.
- •14. Patients who have experienced an exacerbation of COPD or chronic bronchitis (purulent sputum, significant worsening of the symptoms, etc.) in the six weeks prior to the Screening Visit (Visit 1) or between Visits 1 and 3. In the case of an exacerbation during the period between Visits 1 and 3 visits may be postponed up to six weeks.
- •15. Patients who have taken an investigational drug within 1 month or 6 half lives of the active ingredient (what ever is greater) prior to screening visit (Visit 1).
- •16. Patients with a recent history (i.e., one year or less) of myocardial infarction.
- •17. Patients with a recent history (i.e., three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
- •18. Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years.
- •19. Patients who have had changes in their pulmonary therapeutic plan within the last four weeks prior to the Screening Visit (Visit 1).
- •20. Previous participation in this study, or current participation in other clinical study.
- •21. Women are of child-bearing potential or who have not been post menopausal for a duration of less than 2 years and have not a hysterectomy or tubal ligation procedure.
- •22. Patients using anticoagulation or antiplatelet therapy (within 6 half lives time prior to bronchoscopy procedure) or those that have a predisposition to uncontrolled bleeding events.
- •23. Donation of greater than 100 mL of blood within the past 2 weeks prior to screening.
- •24. Patients with known hypersensitivity to lactose or any other components of the inhalation capsule delivery system.
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