Active not recruitingPHASE3INTERVENTIONAL

A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

This research study is looking at a new combination medicine called TEV-56248, given through an inhaler. It contains two medicines, fluticasone propionate and albuterol sulfate. The main goal is to find out if this new inhaler is better at stopping severe asthma attacks than a standard albuterol inhaler alone. We'll also be checking if a lower dose of the new inhaler has similar benefits and how it affects the need for steroid tablets. Patient safety and how well people tolerate the new inhaler are also very important parts of the study. This is a Phase 3 study, meaning it's one of the final steps before a medicine might become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Enrolment target

2,772

Start

30 Aug 2023

Estimated completion

31 Oct 2026

Asthma

What is this study about?

This study is investigating a new type of inhaler that combines two existing asthma medicines: fluticasone propionate and albuterol sulfate. You might already know these as a 'preventer' medicine (fluticasone, a steroid to reduce inflammation) and a 'reliever' medicine (albuterol, to open airways). The idea is to see if putting them together in a specific way (TEV-56248) can work better at preventing severe asthma attacks than using albuterol alone. Severe asthma attacks, also called exacerbations, can be very serious and sometimes require hospital visits or emergency care.

The main aim is to see if this new combination inhaler can reduce the number of serious asthma attacks. We're also curious if a lower strength of this combination inhaler can still be effective and if it means people need fewer steroid tablets, which can have side effects if used often. On top of that, checking how safe the new inhaler is and if people can use it comfortably is a key part of the research.

Taking part would mean using the study inhalers and being carefully monitored by the research team. This helps us understand if the new treatment is helpful and safe enough to potentially be used more widely in the future for people living with asthma.

Key takeaways

This study is testing a new combination inhaler for asthma.
It aims to see if it's better at preventing asthma attacks than a standard inhaler.
Participation could last from about 7 months to over 3 years.
You won't know which treatment you're receiving during the study.
You'll have regular medical check-ups for your asthma.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to have been diagnosed with asthma for at least a year and had at least one severe asthma attack in the last year. You should also be currently taking an inhaled asthma 'preventer' medicine that you've been on for at least a month.

There are some reasons why you wouldn't be able to join. For example, if you've had a very severe, life-threatening asthma attack recently that required special care, or if you've had a bad chest infection that hasn't cleared up. If you've recently had COVID-19 with ongoing symptoms, or an asthma attack requiring steroid tablets or hospitalisation in the last month or two, you also wouldn't be able to take part. Current smokers, or those who've smoked heavily in the past, or anyone who has recently misused alcohol or drugs, would also not be eligible. If you are pregnant, breastfeeding, or planning to get pregnant, you cannot participate. There are other specific details, so the study team can tell you more.

Remember, the study team will ask you questions about your health and medical history to make sure this study is right for you and that taking part would be safe.

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.

Have I had asthma for at least one year?
Did I have a severe asthma attack in the last year?
Am I currently taking an inhaled asthma preventer medicine?
Have I avoided smoking or heavy drinking/drug use recently?
Am I NOT pregnant, breastfeeding, or planning to be pregnant?
Have I been free of serious chest infections or recent bad asthma attacks/hospital stays?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your total time in the study could last anywhere from about 28 weeks (around 7 months) up to about 3 and a half years. This depends on when you join and how long it takes for enough asthma attacks to happen across all participants for the study to gather enough information.

You would first have a 'screening' visit (up to 2 weeks) to check if you're suitable. Then there's an initial period of 2 to 4 weeks where you might switch to a standard inhaler. After this, you would use one of the study inhalers – either the new combination inhaler, a lower dose of it, or the standard albuterol inhaler – for at least 24 weeks (about 6 months). This part is 'double-blind', meaning neither you nor the study team will know which inhaler you are using. You would have regular visits to the clinic for check-ups, to monitor your asthma, and discuss how you are feeling.

Potential risks and benefits

There's a chance that taking part could offer a potential benefit if the new combination inhaler works better for your asthma. You'll also receive careful monitoring of your asthma throughout the study. However, like all medicines, the study inhalers may have side effects, and some might be unpleasant or unexpected. There's also no guarantee that the new inhaler will be better than your current treatment, or that you'll directly benefit. You can stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (393)

Teva Investigational Site 15706
Verified postcode
Birmingham, United States
Teva Investigational Site 15786
Verified postcode
Birmingham, United States
Teva Investigational Site 15768
Verified postcode
Dothan, United States
Teva Investigational Site 15581
Verified postcode
Paradise Valley, United States
Teva Investigational Site 15710
Verified postcode
Scottsdale, United States
Teva Investigational Site 15661
Verified postcode
Tucson, United States
Teva Investigational Site 15685
Verified postcode
Bakersfield, United States
Teva Investigational Site 15721
Verified postcode
Fresno, United States
Teva Investigational Site 15788
Verified postcode
Huntington Beach, United States
Teva Investigational Site 15720
Verified postcode
La Jolla, United States
Teva Investigational Site 15687
Verified postcode
La Palma, United States
Teva Investigational Site 15708
Verified postcode
Long Beach, United States

Common questions

What is an 'asthma exacerbation'?

An asthma exacerbation is another name for an asthma attack, where your asthma symptoms get much worse and you might need extra treatment.

What does 'fixed-dose combination' mean?

It means two different medicines are put together in one single inhaler, so you get both medicines every time you take a puff.

Will I know which inhaler I'm getting?

No, it's a 'double-blind' study, meaning neither you nor the study team will know if you're getting the new inhaler or the standard one until the study is over.

How long will I be in the study?

It could be around 7 months to potentially over 3 years, depending on when you join and how quickly the study collects enough information.

Can I leave the study early if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your regular medical care.