AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A study to compare the relative potency of salbutamol administered via metered dose inhalers containing propellants HFA-152a to HFA-134a in mild asthmatics aged 18 to 65 inclusive.

This research study is for adults aged 18 to 65 who have mild asthma. We are testing a new type of gas used in metered dose inhalers, which are the spray inhalers widely used for asthma. The main goal is to compare how effective this new gas (called HFA-152a) is compared to the gas currently used (HFA-134a) in delivering salbutamol, a common asthma medicine. By doing this, we hope to understand if future inhalers using this new gas will work just as well as the ones you might be using now. This is an early stage study to understand the medicine better.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

18 Sep 2024

Mild Asthma

What is this study about?

This study is all about trying to improve how we deliver asthma medication. You might be familiar with metered dose inhalers, often called 'puffers,' which deliver a measured spray of medicine directly into your lungs. These inhalers use a special gas called a propellant to push the medicine out.

Currently, many inhalers use a propellant called HFA-134a. Scientists are always looking for ways to make medicines and their delivery systems even better. This study is focusing on a new propellant, HFA-152a. We want to find out if inhalers using this new gas deliver the asthma medicine salbutamol just as effectively as inhalers with the current gas. It's like comparing two different types of spray cans to see if they both deliver the same amount of paint evenly.

Understanding how these different propellants work is an important step in making sure that any future asthma inhalers are both safe and effective. This is an early stage, exploratory study, which means we are gathering basic information about how this new propellant works in people with mild asthma.

Key takeaways

This study evaluates a new type of gas in asthma inhalers.
It aims to see if the new gas delivers salbutamol as effectively as current ones.
Participants are adults (18-65) with mild asthma.
It’s an early-stage study to gather basic information.
Your involvement could help improve future asthma treatments.

Who may be eligible?

This study is looking for volunteers who are adults, specifically those aged between 18 and 65 years old. Both men and women are welcome to take part.

To be considered for this study, you must have been diagnosed with mild asthma. This means your asthma symptoms are manageable and generally not severe. You won't be able to join if your asthma is more severe or if you have other serious health conditions that might interfere with the study results or your safety.

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 65 years old?
Do you have a diagnosis of mild asthma?
Are you able to attend several clinic visits?
Are you generally in good health apart from your asthma?
Are you comfortable with breathing tests and potential blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several visits to the study clinic over a period of time. During these visits, you will use the study inhalers, which contain either the new propellant or the current one. You won't know which one you are using, and neither will the study team. You'll have regular health checks, including breathing tests (like spirometry), and we might take some blood or urine samples to check your general health and how your body reacts to the medication. We will also ask you questions about your asthma symptoms and how you feel. The total duration of your involvement in the study will be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from taking part, but your contribution will help doctors learn more about asthma treatments, which could help future patients. Potential risks could include side effects from the salbutamol medication, which are usually mild and well-known, like a slight tremor or fast heartbeat. The new propellant itself will also be carefully monitored. You will be closely looked after by the medical team throughout the study and can withdraw at any time without giving a reason.

Locations (4)

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

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Unverified
Germany
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Unverified
Romania
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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is salbutamol?

Salbutamol is a common medicine used to quickly relieve asthma symptoms like wheezing and breathlessness. It helps to open up your airways.

What is a propellant in an inhaler?

A propellant is a special gas inside your inhaler that helps to push the medicine out as a fine mist when you press down on it.

What does 'mild asthma' mean?

Mild asthma usually means your symptoms are not constant or severe, and you might only need your 'reliever' inhaler occasionally. Your doctor can tell you if your asthma is considered mild.

Is this a new medicine?

No, this study is looking at a new type of gas (propellant) used in inhalers, not a new asthma medicine itself. The medicine, salbutamol, is already widely used.

Will I know which inhaler I'm using?

No, this is a 'blinded' study, meaning neither you nor the study team will know which type of inhaler you are using. This helps to ensure the results are fair and unbiased.