2024-516808-42-00已完成2 期
Phase-II randomized clinical trial to evaluate the effect of Loratadine associated with Rapamune on Lymphagioleiomyomatosis (LAM).
Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL6 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年9月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- Incidence of adverse effects associated with taking loratadine associated with rapamycin, including nausea, diarrhea, abdominal pain, vomiting, headache, hypertransaminasemia.
研究概览
简要总结
Evaluate the safety profile of loratadine in combination with rapamycin after 48 weeks Assess security (incidence of adverse events according to their intensity,severity, relation to treatment) of the combination of loratadine and rapamycin compared with rapamycin in monotherapy in patients with LAM.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients affected by LAM, over 18 years of age, who present: - Definitive diagnosis of LAM based on international consensus and clinical guidelines, maximum 10 years before randomization. The diagnosis must be certain (after evaluation by the Multidisciplinary Interstice Committee of each participating center).
- •-FEV1 > 35% and DLCO > 20%
- •Oxygen saturation (SatO2) > 85% at rest and without supplemental oxygen
- •Chest CT 12 months before randomization suggestive of LAM
- •Taking stable doses of rapamycin for at least the last 3 months
排除标准
- •Habitual concomitant use (minimum 3 days/week) of any histamine antagonist (including in addition to loratadine, ebastine, and similar).
- •Renal failure: Creatinine clearance (CrCl) <60 ml/min
- •Patients who receive as treatment some powerful inhibitor or CYP liver enzyme inducer during screening or 14 days prior to randomization: antifungals (e.g. ketoconazole, itraconazole), clarithromycin, telithromycin, cobicistate, phenytoin, carbamazepine, barbiturates, rifampicin, protease inhibitors such as atazanavir, ritonavir and saquinavir, or good grapefruit intake.
- •Allergic asthma or other major allergic disorder that requires daily or habitual taking of anti-histamines.
- •Other coexisting serious lung disease (in researcher's opinion) such as severe emphysema, bronchiectasis, asthma, severe uncontrolled SAHS.
- •Use of attenuated vaccines while taking Rapamune (according to the technical data sheet of this drug), and patients with lactose intolerance (according to the technical data sheet of loratadine).
- •Hypersensitivity to histamine antagonists or anti-histamines, especially the HR1 receptor.
- •Pregnancy.
- •Breastfeeding and desire to procreate in the year following inclusion.
- •Inadequate contraceptive treatment. In the case of women of age fertile (between menarche and menopause) only those who follow contraceptive methods recommended by the Clinical Trial Facilitation Group (CTFG) will be included during treatment with the drug and during the 12 weeks following its interruption.
- •Active smoking (at the time of study or taking last cigarette less than 3 months ago).
- •Use of immunosuppressants or systemic immunomodulators or chemotherapy within 30 days of screening.
- •Take oral corticosteroids at doses > 15 mg/day, vasodilator therapies for pulmonary arterial hypertension (for example, bosentan), unapproved or investigational drugs for LAM in the period of 4 weeks before the screening visit.
- •Severe liver failure.
结局指标
主要结局
Incidence of adverse effects associated with taking loratadine associated with rapamycin, including nausea, diarrhea, abdominal pain, vomiting, headache, hypertransaminasemia.
Incidence of adverse effects associated with taking loratadine associated with rapamycin, including nausea, diarrhea, abdominal pain, vomiting, headache, hypertransaminasemia.
次要结局
- - Maintenance of clinical stability (FEV1 drop < 10% or DLCO < 15%)
- - Decrease in the number of hospitalizations for any cause and respiratory causes
- - Lung transplant
- - Death.
研究者
María Molina
Scientific
Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
研究点 (6)
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