Bosentan, an endothelin-receptor antagonist, in the treatment of pulmonary hypertension in severe chronic obstructive pulmonary disease: a prospective, double-blind, placebo-controlled trial

niversity Hospital Basel (USB) (Switzerland)0 个研究点目标入组 24 人开始时间: 2006年4月20日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Patients with a diagnosis of severe (forced expiratory volume in one second [FEV1] less than 50%), or very severe (FEV1 less than 30%) COPD and/or severe emphysema (markedly impaired diffusion capacity), according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines will be included in the study. Post-bronchodilator lung function test will be appreciated, as suggested in the guidelines. Patients will be screened in regard to echocardiographical technical feasibility. Moreover, patients will undergo routine clinical, land laboratory evaluation as well as full lung function testing.
•2. Greater than 18 years of age
•3. Postmenopausal women or women with negative pre-treatment pregnancy test as well as a reliable method of contraception during study treatment and for at least three months after study treatment termination. Reliable methods of contraception are:
•3.1. Barrier type devices (e.g. female condom, diaphragm, contraceptive sponge) only in combination with a spermicide
•3.2. Intra-uterine devices
•3.3. Oral, injectable or implantable contraceptives only in combination with a barrier method
•3.4. Hormone-based contraceptives alone, regardless of the route of administration, are not considered as reliable methods of contraception
•3.5. Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception

•1. Mental disorder preventing appropriate judgment concerning study participation
•2. Significant comorbidity resulting in reduced life expectancy
•3. Infectious or non-infections hepatitis
•4. Known intolerance to bosentan
•5. Significant exacerbation of COPD within the last month
•6. Insufficient technical quality in the echocardiographic evaluation
•7. Systolic Blood Pressure (BP) less than 85 mmHg
•8. Body weight less than 40 kg
•9. Hemoglobin concentration less than 75% of the lower limit of the normal range
•10. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) values greater than 3 times the upper limit of normal
•11. Moderate to severe hepatic impairment (Child-Pugh B or C)
•12. Patients with decompensated and/or not corrected right heart failure
•13. Concomitant treatment with:
•13.1. Calcineurin-inhibitors (e.g. cyclosporine A and tacrolimus, everolimus, sirolimus)
•13.2. CYP2C9 and CYP3A4 inhibitors (e.g. fluconazole, amiodarone, miconazole, ketoconazole, itraconazole, ritonavir, voriconazole, metronidazole)
•13.3. Protease inhibitors (e.g. ritonavir) or glibenclamide (glyburide) within 1 week of randomisation

发起方

niversity Hospital Basel (USB) (Switzerland)