EUCTR2006-000418-20-SE进行中（未招募）不适用
A 4-week randomized, double-blind, placebo controlled, parallel group, phase II study to assess the efficacy and safety of gefitinib tablets, 250 mg once daily (OD), in adult patients with moderate chronic obstructive pulmonary disease (COPD) - GECO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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. Out-patients, men or post menopausal or surgically sterile women =40-=80years of age.
- •2. A clinical diagnosis of COPD with symptoms for at least 2 years (GOLD 2003 guidelines) prior to Visit 1.
- •3. A history of chronic cough with sputum production during the last year prior to Visit 1.
- •4. FEV1/VC<70% at Visit 1.
- •5. Post-bronchodilator FEV1=50-<80% of PN at Visit 1.
- •6. Current or previous smoker with a smoking history equivalent to 10 or more pack years.
- •7. Provision of Informed Consent Form could be obtained at an information visit prior to Visit 1 or at Visit 1 (according to local regulations), but before any study related procedures had been performed.
- •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. A history of asthma (in accordance with GINA 2002 guidelines).
- •2. History of allergic rhinitis.
- •3. Use of oral and/or inhaled GCS within 1 month prior to visit 1.
- •4. Women of childbearing potential.
- •5. Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant.
- •6. Patients with a history of concurrent idiopathic pulmonary fibrosis/interstitial pneumonia/pneumoconiosis/radiation pneumonia/drug-induced pneumonia.
- •7. Exacerbation of COPD within 30 days prior to visit 1 requiring hospitalisation, a course of antibiotics and/or a course of increased doses of oral and/or inhaled GCS and/or parenteral treatment and/or nebulized treatment.
- •8. Drug allergy of any kind.
- •9. Patients currently treated with warfarin, or patients who have been treated with warfarin within 3 months prior to Visit 1.
- •10. Patients with liver transaminases, or bilirubin elevated above upper limit of normal (ULN) should not be included in the study.
- •11. Patients suffering from albuminuri (=2, or equiv.) and/or hematuria should not be included in the study.
- •12. Gastrointestinal infections or disease during the last 1 month prior to Visit 1.
- •13. A marked baseline prolongation of QT/QTc (eg, repeated demonstrations of a QTc interval >450 ms for females and >430 ms for males).
- •14. A history of additional risk factors for Torsade de pointes (eg. heart failure, hypokalemia, family history of Long QT syndrome).
- •15. The use concomitant medications that prolong the QT/QTc interval other than albuterol and terbutaline.
- •16. Use of oral or ophthalmic non-cardioselective beta-blocking agents.
- •17. Body Mass Index (BMI) <18 kg/m2.
- •18. Weight<50 kg.
- •19. Significant or unstable ischaemic heart disease, arrhytmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator.
- •20. Any significant disease or disorder (eg gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) or abnormal laboratory tests which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patients ability to participate.
- •21. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at Visit 1, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
研究者
相似试验
进行中（未招募）
不适用
A 4-week randomized, double-blind, placebo controlled, parallel group, phase II study to assess the efficacy and safety of gefitinib tablets, 250 mg once daily (OD), in adult patients with moderate chronic obstructive pulmonary disease (COPD) - GECOEUCTR2006-000418-20-NOAstraZeneca AB150
进行中（未招募）
不适用
A 4-week randomized, double-blind, placebo controlled, parallel group, phase II study to assess the efficacy and safety of gefitinib tablets, 250 mg once daily (OD), in adult patients with moderate chronic obstructive pulmonary disease (COPD) - GECOModerate Chronic Obstructive Pulmonary Disease (COPD)EUCTR2006-000418-20-FIAstraZeneca AB150
进行中（未招募）
1 期
A 4-week randomized, double-blind, placebo controlled, parallel group, phase II study to assess the efficacy and safety of gefitinib tablets, 250 mg once daily (OD), in adult patients with moderate chronic obstructive pulmonary disease (COPD) - GECOModerate Chronic Obstructive Pulmonary Disease (COPD)EUCTR2006-000418-20-DKAstraZeneca AB150
进行中（未招募）
1 期
A 4-week double-blind, randomized, placebo-controlled, phase II study evaluating the effects of oral pamapimod 150 mg with pioglitazone 10 mg daily on COVID-19 evolution and recovery in non-hospitalized patients infected with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2)COVID-19MedDRA version: 23.0Level: PTClassification code: 10084268Term: COVID-19 Class: 100000004862CTIS2022-500244-37-00Kinarus AG440
进行中（未招募）
1 期
A 4 week randomised, double blind, placebo controlled, parallel group, phase II, PoP study to assess the efficacy and safety of AZD1981 in adult patients with asthma.AsthmaEUCTR2006-001193-25-GBAstraZeneca AB22