EUCTR2012-003037-41-AT进行中（未招募）1 期
Effects of Roflumilast on pulmonary vascular resistance in patients with COPD and sleep apnea (Overlap Syndrome) with and without non-invasive ventilation. A Pilot Study. - Effects of Roflumilast in Overlap Syndrome
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Lungenkrankheiten0 个研究点开始时间: 2012年8月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •This study is aimed to show the effect of roflumilast on pulmonary vascular resistance in
- •patients suffering from both sleep apnea and COPD, the so called overlap syndrome.
- •Therefore inclusion criteria are based on gold standards for each disease separately. Adult
- •patients with an age of >18 years fulfilling both, COPD and sleep apnea criteria, will be
- •invited to participate in this study.
- •Regarding clinical experience and experimental data, pulmonary hypertension can be observed in patients with overlap syndrome even with only mild to moderate COPD. Hence, according to the GOLD criteria, we decided to include patients with COPD corresponding to a forced expiratory volume in 1 second (FEV1) <60% of the predicted value and a ratio of FEV1 to forced vital capacity (FVC) of =70% diagnosed by spirometry. According to the recently published COPD criteria, the inclusion criteria correspond to group B, C and D of the Combined Assessment of COPD test.
- •Sleep Apnea
- •Patients with moderate to severe sleep apnea will be included in this study. Thus, according to the American Association of Sleep Medicine (AASM) criteria, which is considered to be the current gold standard, patients with an AHI > 15 events per hour (moderate 15-30/h, severe >30/h) diagnosed by overnight polysomnography will be included in this study.
- •Pulmonary Hemodynamics
- •As the goal of this study is to investigate the effects of roflumilast on an abnormal pulmonary hemodynamical state, only those patients will be included who present with a PVR>150 dyn×s×cm-5 and a mPAP > 20mmHg at the baseline right heart catheterization.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Underweight is very rare in patients suffering from sleep apnea as significant weight loss is important goal in these patients. Therefore weight loss which is a common side effect of roflumilast may be advantageous in the majority of patients with sleep apnea syndrome.
- •Patients with a body mass index less than 20kg/m² will not be included in this study.
- •Roflumilast is metabolized in the liver through cytochrome-P450 isoenzymes. Hence, roflumilast is contraindicated in patients with with moderate to severe liver failure. Patients with Child-Pugh class B to C will also be excluded from this study.
- •Furthermore, patients working as professional drivers and patients with daytime hypercapnia ( pCO2 >55mmHg) will be excluded from this study.
- •Further exclusion criteria:
- •pregnancy, pulmonary hypertension due to other reasons, active clinical depression, therapy with roflumilast or NIV in history, immunosupression, treatment with combined CYP3A4/CYP1A2 inhibitors.
研究者
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