EUCTR2020-000702-29-ES进行中（未招募）1 期
Phase-II randomized clinical trial to evaluate the effect of Loratadine associated with Rapamune on Lymphagioleiomyomatosis (LAM).
IDIBELL (Institut d’Investigació Biomédica de Bellvitge)0 个研究点目标入组 62 人开始时间: 2021年2月9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
- 入组人数
- 62
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
- Female
入选标准
- •Patients with LAM and > 18 years-old with:
- •- FEV1 > 35% and DLCO > 20%
- •- Oxygen saturation (SpO2) > 85% by pulse oximetry while breathing ambient air at rest.
- •- Patients with a definite diagnosis consistent with LAM prior to screening based on International consensus criteria within 10 years prior to randomization.
- •- HRCT within 12 months prior to randomization with central reading demonstrating a radiological pattern suggesting LAM and some other criteria for initiating sirolimus (symptoms, FEV1 decline or the presence of abdominal lynphangioleiomiomas).
- •- Taking stable doses of rapamycin for at least the last 3 months.
- •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 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •- Concomitant use of other HR1 antagonist.
- •- Hypersensitivity to HR1 antagonists.
- •- Current smoker or ex-smoker having quit smoking < 4 months prior to firs screening visit.
- •- Use of systemic immunosuppressants or chemotherapy within 30 days of screening.
- •- Receiving oral corticosteroids>15mg/day, vasodilator therapies for pulmonary hypertension (e.g., bosentan), unapproved and/or investigational therapies for LAM or administration of such therapies within 4 weeks of initial screening.
- •- At baseline/screening visit, values of liver transaminases above 3 times upper limit, alkaline phosphatase above 2.5 times upper limit, or bilirubin above 1.5 times upper limit.
- •- Creatinine clearance (CrCl)<60ml/min (determined by Cockcroft-Gault Equation) at baseline/screening visit.
- •- Patients treated with strong inhibitors and inducers of CYP either during the study or 14 days prior to enrolment in the study: antifungals (e.g., ketoconazole, itraconazole), clarithromycin, telithromycin, cobicistat, protease inhibitors (e.g., atazanavir, ritonavir, and saquinavir) and grapefruit juice, phenytoin, carbamazepine, barbiturates, rifampin.
- •- Current allergic asthma or other major allergic diseases that requires different daily antihistaminic treatment.
- •- History of coexistent and clinically significant (in the opinion of the Investigator) chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, inadequately treated sleepdisordered
- •breathing, or any clinically significant pulmonary diseases other than LAM.
研究者
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