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Study on the Effects of Loratadine and Rapamycin for Patients with Lymphangioleiomyomatosis (LAM)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for a rare lung disease called lymphangioleiomyomatosis (LAM). LAM is a condition that affects the lungs and can lead to breathing difficulties. The treatment being tested involves a combination of two medications: loratadine and rapamycin. Loratadine is commonly used to treat allergies, while rapamycin is a medication that helps to prevent the growth of certain cells.

The purpose of this study is to evaluate the safety of using loratadine together with rapamycin over a period of 48 weeks. Participants in the study will be randomly assigned to receive either the combination of loratadine and rapamycin or rapamycin alone. The study will monitor the occurrence of any side effects, such as nausea, diarrhea, abdominal pain, vomiting, headache, and changes in liver function, to understand how the combination treatment compares to using rapamycin by itself.

Throughout the study, researchers will also observe the participants' overall health, including their lung function and the number of hospital visits they may need. The study aims to determine if the combination treatment can help maintain clinical stability and reduce the need for hospitalizations. The trial will provide valuable information on whether adding loratadine to the treatment plan for LAM patients is safe and beneficial.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is confirmed to have a definitive diagnosis of lymphangioleiomyomatosis (LAM) based on international guidelines. The diagnosis must have been made within the last 10 years.

    The patient must be over 18 years old and have specific lung function criteria, including FEV1 greater than 35% and DLCO greater than 20%. Oxygen saturation should be above 85% at rest without supplemental oxygen.

    A chest CT scan from the last 12 months should suggest LAM, and the patient must have been on stable doses of rapamycin for at least the last 3 months.

  2. Step 2

    Medication administration

    The patient will take loratadine in combination with rapamycin. Loratadine is administered orally in the form of a 10 mg tablet.

    The combination treatment aims to evaluate the safety profile over a period of 48 weeks.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, the patient will be monitored for any adverse effects associated with the combination of loratadine and rapamycin. These may include nausea, diarrhea, abdominal pain, vomiting, headache, and elevated liver enzymes.

    The primary goal is to assess the safety of the treatment, while secondary goals include maintaining clinical stability, reducing hospitalizations, and monitoring for serious outcomes such as lung transplant or death.

  4. Step 4

    Completion of the trial

    The trial is expected to conclude by January 1, 2025. At the end of the trial, the data collected will be analyzed to determine the safety and effectiveness of the treatment combination.

Who can join the trial?

6 criteria

  • Must be a woman over 18 years old.
  • Must have a confirmed diagnosis of **LAM** (lymphangioleiomyomatosis) based on international guidelines, diagnosed no more than 10 years ago.
  • Must have a **FEV1** (a measure of lung function) greater than 35% and **DLCO** (another lung function measure) greater than 20%.
  • Must have an **oxygen saturation** (SatO2) greater than 85% while at rest and without using extra oxygen.
  • Must have had a chest **CT scan** (a type of detailed X-ray) within the last 12 months that suggests LAM.
  • Must have been taking stable doses of **rapamycin** (a medication) for at least the last 3 months.

Who cannot join the trial?

3 criteria

  • Patients who are not female cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

  • Loratadine

    is a medication commonly used to relieve allergy symptoms such as runny nose, sneezing, and itchy eyes. In this trial, it is being tested for its potential benefits in treating Lymphangioleiomyomatosis (LAM) when used in combination with another medication.

  • Rapamune

    , also known as sirolimus, is a medication that helps prevent organ rejection in transplant patients by suppressing the immune system. In this trial, it is being used to evaluate its effectiveness and safety in treating LAM, both alone and in combination with loratadine.

What is already known about the treatment

  • Loratadine

    Loratadine is typically administered orally in the form of tablets or syrup. It is currently being studied in clinical trials for its potential effects on lymphangioleiomyomatosis (LAM), a rare lung disease. Loratadine is primarily used as an antihistamine to relieve allergy symptoms such as runny nose, sneezing, and itchy eyes. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine belongs to the pharmacological class of second-generation antihistamines, which are known for causing less drowsiness compared to first-generation antihistamines.

  • Rapamycin

    Rapamycin is administered orally, often in tablet form, and is currently being evaluated in combination with loratadine for its effects on lymphangioleiomyomatosis (LAM). It is an established medication used primarily to prevent organ transplant rejection and treat certain cancers. Rapamycin works by inhibiting a protein called mTOR, which plays a key role in cell growth and proliferation. It is classified as an immunosuppressant and an mTOR inhibitor, helping to slow down abnormal cell growth in conditions like LAM.

Investigated diseases

Lymphangioleiomyomatosis – Lymphangioleiomyomatosis is a rare lung disease that primarily affects women, often during their childbearing years. It is characterized by the abnormal growth of smooth muscle-like cells, particularly in the lungs, lymphatic system, and kidneys. Over time, these cells can cause the formation of cysts in the lungs, leading to breathing difficulties and reduced lung function. The disease may also affect the lymphatic system, causing fluid accumulation and swelling in various parts of the body. As the condition progresses, individuals may experience symptoms such as shortness of breath, chest pain, and fatigue. The progression of the disease can vary significantly among individuals, with some experiencing a slow decline in lung function while others may have a more rapid progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516808-42-00Estimated enrolment62 patientsSponsorFundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

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