Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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

This research is a Phase II clinical trial investigating a new treatment approach for women who have a rare lung disease called Lymphangioleiomyomatosis, or LAM. The study aims to understand how a combination of loratadine (a common allergy medication) and rapamycin works in these patients. Doctors want to see if taking these two medicines together causes any side effects, such as sickness, tummy pain, or headaches. They also want to find out if this treatment helps to keep the disease stable, meaning it prevents a decline in lung function, reduces the number of times people need to go to the hospital, or lowers the risk of needing a lung transplant. This is an early exploration to gather important information about this potential treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Enrolment target

Start

19 Sep 2024

Effect of loratadine in patients with lymphangioleiomyomatosis

What is this study about?

This study is looking into a potential new way to treat a rare lung disease called Lymphangioleiomyomatosis, often shortened to LAM. LAM mainly affects women and can cause breathing problems. The research focuses on a combination of two medicines: loratadine, which is a common medication used for allergies like hay fever, and another drug called rapamycin. Rapamycin is already sometimes used for LAM, but doctors want to see what happens when it's given alongside loratadine.

The main goal of this early-stage study is to carefully monitor for any side effects that might occur when these two drugs are taken together. They will be looking out for common issues like feeling sick (nausea), diarrhoea, stomach ache, vomiting, or headaches. They will also check liver function, as sometimes medications can affect this. Understanding these side effects is crucial when testing new treatments.

Beyond side effects, researchers also want to see if this treatment helps keep LAM stable. This means checking if it can prevent a significant drop in lung function over time, reduce the number of hospital visits for any reason (especially breathing problems), and ultimately reduce the chances of needing a lung transplant. This important research could help find better ways to manage LAM in the future.

Key takeaways

This study investigates a new treatment combination for women with LAM.
It combines a common allergy medicine (loratadine) with a LAM drug (rapamycin).
The main goals are to check for side effects and disease stability.
Participation involves regular visits and health checks.
It's a Phase II study, meaning it's an early exploration of a new treatment.

Who may be eligible?

This study is specifically designed for women who have been diagnosed with Lymphangioleiomyomatosis (LAM).

To be considered for this trial, you must be at least 18 years old. There is no upper age limit, meaning women of any adult age can potentially take part if they meet all other criteria.

Since LAM primarily affects women, men are not able to join this particular study. Other specific health requirements, which a doctor can explain, will also need to be met to ensure the study is safe and suitable for you.

Quick self-check

I am a woman.
I have been diagnosed with Lymphangioleiomyomatosis (LAM).
I am 18 years old or older.
I am willing to follow the study schedule and take the study medications.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be given loratadine medication to take alongside rapamycin. You'll have regular visits to the hospital or clinic, where doctors and nurses will monitor your health closely. These visits will involve various assessments, such as physical examinations, blood tests to check for side effects (like liver function), and lung function tests to see how well your lungs are working. They will also ask you questions about how you are feeling and any symptoms you might be experiencing. The total duration of your participation will be explained by the study team, and you'll have follow-up appointments to track your progress and well-being after the main treatment phase.

Potential risks and benefits

By taking part in this study, you might contribute to the development of a better treatment for LAM, potentially helping yourself and others in the future. However, there's no guarantee that you will personally benefit from the treatment. Potential risks include experiencing side effects from the medication combination, such as nausea, diarrhoea, or headaches, similar to what is listed. The study team will monitor you closely for any unwanted effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Spain

Common questions

What is LAM?

LAM is a rare lung disease that mostly affects women and can cause breathing problems due to unusual growth of certain cells in the lungs.

What are loratadine and rapamycin?

Loratadine is a common anti-allergy medicine. Rapamycin is a drug often used to treat LAM, and this study looks at what happens when it's combined with loratadine.

Why is this study important?

This study helps doctors learn more about how a combination of medicines works for LAM, hoping to find safer and more effective ways to manage the disease and improve patients' lives.

What kind of side effects might I experience?

Potential side effects could include feeling sick, having diarrhoea, stomach pain, vomiting, or headaches. The study team will monitor you closely for these.

Will I definitely get the new treatment?

This is a 'randomised' study, meaning participants are randomly assigned to a treatment group. Your doctor will explain exactly what this means for you.