Evaluating the effect of Loratadine associated with Rapamune in Lymphagioleiomyomatosis (LAM).

Phase-II randomized clinical trial to evaluate the effect of Loratadine associated with Rapamune on Lymphagioleiomyomatosis (LAM).

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000702-29-ES

Enrollment

Registered

2021-02-09

Start date

2021-06-07

Completion date

Unknown

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EFFECT OF LORATADINE ON LYMPHANGIOLEIOMYOMATOSIS MedDRA version: 21.0 Level: PT Classification code 10049459 Term: Lymphangioleiomyomatosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Loratadina STADA 10 mg Product Name: Loratadina Stada Pharmaceutical Form: Capsule INN or Proposed INN: LORATADINE CAS Number: 79794-75-5 Other descriptive name: LORATADINE Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: - Concomitant use of other HR1 antagonist. - Hypersensitivity to HR1 antagonists. - Current smoker or ex-smoker having quit smoking 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the safety profile of loratadine in combination with rapamycin after 52 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.;Secondary Objective: The secondary objectives evaluate: a) quality of life and progression free-survival time, b) changes in the established LAM serum biomarker VEGFD, c) the utility of the major histamine-derived metabolite methylimidazoleacetic acid (MIAA) for monitoring disease progression and biological treatment effect.;Primary end point(s): Incidence of adverse effects associated with taking loratadine associated with rapamycin, including nausea, diarrhea, abdominal pain, vomiting, headache, hypertransaminasemia.;Timepoint(s) of evaluation of this end point: The assessment of the primary point is at 52 weeks	—

Measure

Time frame

Main Objective: Evaluate the safety profile of loratadine in combination with rapamycin after 52 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.;Secondary Objective: The secondary objectives evaluate: a) quality of life and progression free-survival time, b) changes in the established LAM serum biomarker VEGFD, c) the utility of the major histamine-derived metabolite methylimidazoleacetic acid (MIAA) for monitoring disease progression and biological treatment effect.;Primary end point(s): Incidence of adverse effects associated with taking loratadine associated with rapamycin, including nausea, diarrhea, abdominal pain, vomiting, headache, hypertransaminasemia.;Timepoint(s) of evaluation of this end point: The assessment of the primary point is at 52 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): -Progression-free survival time, which will be considered when some of these events are present: FEV1 decrease > 10%, DLCO decrease > 15%, lung transplant, death. -Hospitalization. Registration of any cause of hospitalization;Timepoint(s) of evaluation of this end point: The assessment of the primary point is at 52 weeks	—

Countries

Spain

Contacts

Public ContactMaria Molina Molina

Maria Molina Molina

mariamolinamolina@hotmail.com0034932606600

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026