Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized, double-blind, parallel group, multi-center study to evaluate the long-term safety of salbutamol rescue medication when administered via metered dose inhalers containing the propellant HFA-152a or reference HFA-134a.

This study focuses on the long-term safety of a widely used asthma 'reliever' inhaler, like Ventolin. Researchers are comparing two similar inhalers, both designed to quickly relieve asthma symptoms by opening up your airways. The main difference is a new, environmentally friendlier ingredient in one of the inhalers. The study aims to find out if using this new version over three months causes any unexpected side effects to your health. They'll be carefully checking for any health problems that might come up. This type of research helps make sure that new medications, even small changes to existing ones, are safe for everyone who needs them, especially for long-term use in managing conditions like asthma.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

227

Start

10 Jun 2024

Asthma

What is this study about?

Imagine you have asthma and rely on your 'reliever' inhaler to quickly ease breathlessness. This study is all about making sure that these important medications continue to be as safe as possible.

Researchers are looking specifically at a common asthma relief inhaler. There are two slightly different versions of this inhaler being compared. Both versions work in the same way – they contain a medicine called salbutamol that helps to open up your airways when you have asthma symptoms. However, one version uses a newer, more environmentally friendly ingredient called HFA-152a, while the other uses an older, well-known ingredient called HFA-134a.

The main goal of the study is to see if using the inhaler with the new ingredient over three months causes any unexpected health problems or side effects. This involves very careful monitoring to check for any changes in your health. Understanding the long-term safety of even small changes to medicines is really important to ensure that future treatments for asthma are both effective and safe for everyone.

Key takeaways

This study is testing the long-term safety of a common asthma 'reliever' inhaler.
It compares two versions of the inhaler, one with a newer, greener ingredient.
Participation involves using an inhaler for three months and attending clinic visits for health checks.
The study aims to confirm there are no unexpected side effects with the new ingredient.
All participants must be at least 18 years old and have asthma.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have been diagnosed with asthma.

There might be other health conditions or medications that would prevent you from joining, as the researchers need to make sure the study environment is safe and that the results are clear. For example, if you have certain other serious health issues, particularly related to your heart or kidneys, you might not be able to participate. Similarly, if you're taking specific medicines that could interfere with the study drug, you might also be excluded. Your study doctor would discuss all of this with you in detail.

Essentially, the study needs healthy adults with asthma to help them understand how the new inhaler ingredient affects them over time, without other health problems complicating the results.

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 18 years old or older?
Have you been diagnosed with asthma?
Are you able to attend regular clinic visits for three months?
Are you willing to use one of the study inhalers for three months?
Do you understand that you won't know which inhaler you're using?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be using one of the two study inhalers as your usual asthma relief medication for three months. You won't know which version you're using. Throughout this time, you'll have several visits to the clinic.

During these visits, the study team will carry out various checks. This includes blood and urine tests to look at things like your potassium levels and overall health. They'll also check your vital signs, such as your blood pressure and heart rate, and perform an ECG (a heart tracing) to monitor your heart's activity. You might also complete questionnaires about your asthma symptoms, and have your lung function tested using a breathing test called FEV1.

After the three months of using the inhaler and attending clinic visits, there will be a final check-up. The total duration of your active involvement in the study, including all follow-up, will be around three months.

Potential risks and benefits

Participating in a study like this helps advance medical knowledge and could contribute to safer asthma treatments for the future. You will also receive careful medical monitoring throughout the study. However, there's always a chance you might experience side effects from the medication, even though both inhalers are very similar to ones already in use. Some tests, like blood draws, may cause minor discomfort. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
France
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Unverified
Greece
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Unverified
Italy
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Unverified
Poland

Common questions

What is an 'AE'?

An 'AE' stands for 'Adverse Event,' which is any unwanted medical problem that happens to a patient during a clinical study, whether it's related to the study medication or not.

What is the difference between HFA-152a and HFA-134a?

These are different types of gases, called propellants, used in inhalers to help push the medicine out. HFA-152a is a newer version that's considered more environmentally friendly than HFA-134a.

Will I know which inhaler I'm using?

No, this is a 'double-blind' study, meaning neither you nor the study team will know which of the two inhalers you are using. This helps make the study fair and unbiased.

What does a 'Phase III' study mean?

Phase III means this is a large study that aims to confirm the safety and effectiveness of a treatment after it has shown promise in earlier, smaller studies. This is often the last step before a new treatment can be widely approved.

What is 'serum potassium'?

Serum potassium is a measurement of the amount of potassium in your blood. Potassium is an important mineral that helps your nerves and muscles, including your heart, work properly.