In short
There is currently 1 ongoing clinical trial for lymphangioleiomyomatosis (LAM), a rare lung disease that primarily affects women. This trial is investigating the combination of loratadine and rapamycin to evaluate safety and potential benefits for patients with this condition.
Clinical trial locations
- Spain
Study on the Effects of Loratadine and Rapamycin for Patients with Lymphangioleiomyomatosis (LAM)
This clinical trial is examining whether adding loratadine to rapamycin treatment is safe and beneficial for women with lymphangioleiomyomatosis. The study is being conducted in Spain and follows participants for 48 weeks to carefully monitor their response to treatment.
Who can participate:
- Women over 18 years old
- Confirmed diagnosis of LAM according to international guidelines, made within the last 10 years
- Specific lung function requirements: FEV1 (a measure of how much air you can exhale) greater than 35% and DLCO (a measure of oxygen transfer) greater than 20%
- Oxygen saturation above 85% at rest without needing supplemental oxygen
- A chest CT scan from the past 12 months showing signs consistent with LAM
- Already taking stable doses of rapamycin for at least 3 months
Who cannot participate:
- Men cannot participate in this trial
- Women outside the specified age range
- Individuals considered part of a vulnerable population
What the trial involves:
The study is testing whether combining loratadine with rapamycin is safe and effective. Loratadine is a medication commonly used for allergies, while rapamycin (also known as Rapamune or sirolimus) is a medication that helps prevent abnormal cell growth by blocking a protein called mTOR. Participants will be randomly assigned to receive either the combination of both medications or rapamycin alone.
Throughout the 48-week study period, researchers will carefully monitor participants for any side effects, including nausea, diarrhea, abdominal pain, vomiting, headache, and changes in liver function. The trial will also track overall health markers such as lung function and the number of hospital visits needed. The main goal is to determine if adding loratadine to the standard rapamycin treatment is safe and whether it helps maintain clinical stability and reduce hospitalizations.
Investigational drugs:
Loratadine is administered orally as a 10 mg tablet. While typically used to relieve allergy symptoms by blocking histamine, it is being studied here for its potential benefits in treating LAM when combined with rapamycin.
Rapamycin (Rapamune) is taken orally, usually in tablet form. It works by inhibiting the mTOR protein, which plays a key role in cell growth. Originally developed to prevent organ transplant rejection, it has shown promise in slowing abnormal cell growth in conditions like LAM.
Summary
Currently, there is only one active clinical trial for lymphangioleiomyomatosis, located in Spain. This trial focuses on evaluating the safety of combining loratadine with rapamycin for women already taking rapamycin as their standard treatment. The study represents an important effort to explore whether adding a commonly available allergy medication might enhance treatment outcomes for this rare lung disease. Women with LAM who meet the specific lung function criteria and are already on stable rapamycin therapy may wish to discuss this trial opportunity with their healthcare provider.
