Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to compare the pharmacokinetics of salbutamol administered via metered dose inhalers containing propellants HFA-152a (test) or HFA-134a (reference) in healthy participants aged 18 to 55 inclusive.

This study aims to compare two different types of asthma inhalers. Both inhalers deliver the same asthma medicine, salbutamol, but use slightly different propellants (the gas that helps push the medicine out). We want to understand how the body takes in and uses salbutamol from each of these inhalers. To do this, we are looking for healthy volunteers between the ages of 18 and 55. This research is important because it helps ensure that new versions of common medicines, like asthma inhalers, work as expected and are safe for people to use. By understanding how the body processes the medicine, we can ensure future treatments are effective.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

21 May 2024

Healthy volunteers

What is this study about?

This research study is about asthma inhalers, specifically the kind that deliver a medicine called salbutamol. Many people use salbutamol inhalers to help with their breathing, for example, if they have asthma. Inhalers use a special gas called a propellant to push the medicine out so you can breathe it in.

Here, we're comparing two different inhalers. Both contain the same helpful medicine, but one uses a new type of propellant, and the other uses an older, well-known type. The main goal is to see how the body absorbs and processes the salbutamol from each of these inhalers. This is important because even small changes in how a medicine is delivered can affect how well it works and how safe it is.

By comparing these two inhalers in healthy people, we can learn valuable information. This helps scientists and doctors make sure that any new inhaler designs are just as good, or even better, than the current ones. It’s a key step in ensuring that people who rely on these medicines continue to get the best possible care.

Key takeaways

The study compares how two different asthma inhalers deliver salbutamol medicine.
It aims to understand how the body absorbs this medicine from both types of inhalers.
They are looking for healthy adults aged 18 to 55.
Participation involves clinic visits and blood tests to monitor medicine levels.
Your contribution helps ensure new medicines are safe and effective.

Who may be eligible?

To take part in this study, you need to be a healthy adult. This means you generally feel well and don't have any major ongoing health problems or take regular medications for chronic conditions. We are looking for people who are in good physical shape.

You must be between 18 and 55 years old, including both these ages. Whether you are male or female, you are welcome to consider participating if you meet the health and age requirements.

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 55 years old (inclusive)?
Are you generally healthy and don't have major long-term health problems?
Do you currently take regular medication for any ongoing health conditions?
Are you willing and able to attend clinic visits as required by the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given doses of salbutamol from both types of inhalers being studied. This will likely involve a few visits to a clinic. During these visits, doctors and nurses will monitor your health and take blood samples at specific times to check how the salbutamol is moving through your body. There will be no long-term follow-up once the clinic visits are complete. The exact number of visits and the total duration in the study will be explained in detail by the study team, but typically, these types of studies involve a few days of participation.

Potential risks and benefits

Taking part in a study like this provides important information that can help improve future treatments for people with breathing conditions. You would be contributing to scientific knowledge. Potential risks might include minor discomfort from blood draws, or very rare short-term side effects from the salbutamol itself, even in healthy individuals, such as a temporary fast heartbeat or slight tremor, which are usually mild and wear off quickly. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is salbutamol?

Salbutamol is a common medicine used to open up the airways in the lungs, making it easier to breathe. It's often found in 'reliever' inhalers for asthma.

What is a propellant in an inhaler?

The propellant is a gas inside the inhaler that helps push the medicine out as a fine mist when you press down, so you can inhale it into your lungs.

Why do you need healthy volunteers?

Using healthy volunteers helps gather clear information about how the body handles the medicine without interference from other illnesses or medications. This provides a baseline understanding.

Will I get to keep the inhalers?

No, the inhalers used in the study are for research purposes only and will be managed by the study team. You will not take them home.

Will the study cost me anything?

Participating in research studies like this typically does not cost you anything. You might even receive some compensation for your time and travel.