Active not recruitingPHASE3INTERVENTIONAL

Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma

This study is for adults aged 18-70 with asthma that isn't fully controlledby their current inhalers. Researchers are testing a new inhaler that combines three different medicines into one daily dose. These medicines work together to reduce swelling in the lungs and open up the airways. The study will use special MRI scans, which involves inhaling a safe gas, to get detailed pictures of how air moves through the lungs. This helps doctors see if the new inhaler improves how evenly air spreads. They will also use standard lung tests and ask participants to fill out questionnaires to compare these results with the scan findings. The goal is to see how effective this new triple therapy is at improving lung function and overall asthma control.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Dr. Grace Parraga

Enrolment target

Start

08 Aug 2022

Estimated completion

01 Dec 2025

Asthma

Results

Results from this study

Posted March 2024

Results have been published for this study.

Primary outcome

Change From Baseline Airway Function Measured Using 129-Xenon MRI Ventilation Defect Percent at the End of 6 Weeks of Treatment With FF/UMEC/VI 200/62.5/25ug Once Daily

Change in VDP

Full results on the registry

What is this study about?

This research study is looking for volunteers between 18 and 70 years old who have asthma that isn't completely controlled, even though they're already using two types of inhaler medicines.

The study evaluates a new type of inhaler called 'triple therapy'. This inhaler is special because it combines three different asthma medicines into one puff, taken once a day. Each medicine plays an important role: one helps reduce inflammation (swelling) in the lungs, and the other two work to open up the airways, making it easier to breathe.

To see how well this new inhaler works, the researchers will use a couple of special methods. One involves a type of MRI scan where you inhale a safe gas called xenon. This gas lights up on the MRI, allowing doctors to see how air gets into different parts of your lungs. In healthy lungs, the air spreads evenly, but in asthma, it might spread unevenly, showing up as 'patchy' areas. They'll also do a regular CT scan to look at the structure of your lungs, along with standard breathing tests and questionnaires about your asthma symptoms, to compare with the MRI results. This will help them understand if the new inhaler is making a difference to your breathing and lung health.

Key takeaways

This study tests a new 'triple therapy' inhaler for poorly controlled asthma.
It uses special MRI scans to see how air moves in the lungs.
Participation involves 5 visits over 8 weeks, including scans and breathing tests.
The new inhaler combines three medicines into one daily dose.
You must be an adult with a specific type of asthma and already using other inhalers.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old who has been diagnosed with eosinophilic asthma. This is a specific type of asthma where a certain kind of white blood cell is higher than usual. You should already be using a medium-dose combination inhaler (steroid and long-acting bronchodilator) for at least six months, and your asthma should still not be fully controlled.

Your breathing tests will need to show that your lung function is within a certain range (specifically, your FEV1, a measure of how much air you can exhale, should be between 35% and 80% of what's expected).

It’s also important that you haven't smoked or vaped any products, including tobacco or cannabis, for at least a year before the study starts. For women who could become pregnant, you'll need to use a very effective form of birth control throughout the study and for eight weeks afterwards. Men who are sexually active will also need to use double barrier contraception during the study and for eight weeks after finishing the study medicine.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Have you been diagnosed with a specific type of asthma called 'eosinophilic asthma'?
Are you currently using a medium-dose combination inhaler but still have uncontrolled asthma?
Have you not smoked or vaped anything for at least the last year?
If you are a woman who could become pregnant, are you willing to use effective birth control throughout the study?
If you are a man who is sexually active, are you willing to use double barrier contraception throughout the study?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve five visits over about eight weeks. The first visit, called the screening visit, happens two weeks before the main study starts to check if you're suitable. The next visit kicks off the main part of the study, and you'll have another main visit six weeks later.

During these main visits, you'll have several tests before and after taking your study medication (or a standard reliever inhaler). These include having your vital signs checked, breath tests (like FeNO, spirometry, and others), and those special MRI scans with xenon gas to see how air moves in your lungs. You will also have a CT scan at the start of the study. You will be asked to fill out questionnaires about your asthma and general health.

There's an optional check-up around week three, which can be a quick clinic visit or a phone call. Finally, there's a phone call eight weeks after your last study medicine dose, mainly to check on your well-being and any side effects. You'll be using the new triple therapy inhaler once a day throughout the study period.

Potential risks and benefits

Taking part in this study could potentially improve your asthma control and breathing with the new triple therapy inhaler, and you would be contributing to valuable medical research. As with any medication or medical procedure, there are potential risks, side effects from the medication, or discomfort from the tests like the MRI scans. The researchers will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
Verified postcode
London, Canada

Common questions

What is 'triple therapy'?

Triple therapy is a new inhaler for asthma that contains three different medicines in one dose to help reduce swelling and open up your airways.

What are the special scans for?

The special MRI scans, using a harmless gas, help doctors see exactly how air is moving inside your lungs and whether the new medicine is helping it spread more evenly.

How long will the study last?

The study involves five visits over about eight weeks, including follow-up phone calls.

Will I stop my current asthma medicine?

You will be given the new triple therapy inhaler, which combines medicines. You'll need to follow specific instructions about your current inhalers during the study visits.

Who is paying for this study?

The study is sponsored by a pharmaceutical company, but all details and findings are carefully reviewed and monitored for safety and accuracy.