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Phase-II randomized clinical trial to evaluate the effect of Loratadine associated with Rapamune on Lymphagioleiomyomatosis (LAM).
EU CTIS ID: 2024-516808-42-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- -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
You likely can't join if
- - 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).
See the full eligibility criteria
- -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
- - 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.