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RecruitingPHASE3INTERVENTIONAL

A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma

This research is looking at a new asthma inhaler that contains a combination of two medicines: fluticasone propionate and albuterol sulfate. It's designed for people aged 12 and older who have asthma. The study aims to find out if this new combination inhaler, delivered as a dry powder, works better than each medicine on its own, or a dummy inhaler with no medicine (a placebo). Researchers also want to understand if the new inhaler is safe to use and how the medicine acts in the body after a single dose. Participants in the study will be involved for about 10 weeks.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Teva Branded Pharmaceutical Products R&D LLC
Enrolment target
724
Start
12 Dec 2024
Estimated completion
19 Sep 2026

What is this study about?

This study is a clinical trial exploring a new inhaler for treating asthma. The inhaler combines two common asthma medicines: fluticasone propionate and albuterol sulfate. Fluticasone propionate helps to reduce inflammation in the airways, making breathing easier over time. Albuterol sulfate is a fast-acting medicine that helps to open up the airways quickly when you're having asthma symptoms. This trial is trying to see if combining these two medicines into one new type of dry powder inhaler works effectively and safely for people with asthma.

To do this, the study will compare this new combination inhaler against several other options. Some people will receive only fluticasone propionate, others only albuterol sulfate, and some will receive a 'placebo' – an inhaler that looks the same but contains no active medicine. This allows the researchers to fairly assess if the new combination is better than the individual parts or no treatment at all. The study will also carefully check for any side effects and how the medicines are absorbed by the body.

Taking part in a study like this is a way for new treatments to be properly checked before they can be made available more widely. It's important for researchers to understand both the benefits and potential risks of any new medicine.

Key takeaways

  • Tests a new combination inhaler for asthma.
  • Aimed at people 12 years and older with asthma.
  • Compares new inhaler to individual medicines and a dummy inhaler.
  • Investigates how well it works and its safety.
  • Participation lasts about 10 weeks.
  • You can leave the study at any time.

Who may be eligible?

To be part of this study, you generally need to be 12 years old or older and have been diagnosed with asthma for at least six months. You should also be using a 'reliever' inhaler (like salbutamol or albuterol) for your asthma symptoms, whether you use other daily asthma medicines or not. If you are female, you must not be pregnant, breastfeeding, or planning to become pregnant during the study period. Your doctor can provide more details if you think you might be eligible.

There are also some reasons why you might not be able to join. For example, if you've ever had a very severe asthma attack that caused you to be put on a breathing machine, or if you've had a bad chest infection recently. If you smoke or used tobacco products in the last six months, or have other serious lung conditions like COPD, you would not be able to participate. It's always best to discuss your full medical history with the study doctor.

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.

  1. Are you 12 years old or older?
  2. Do you have an asthma diagnosis that's at least 6 months old?
  3. Do you currently use a 'reliever' inhaler for your asthma?
  4. If you are female, are you not pregnant, breastfeeding, or planning a pregnancy in the next few months?
  5. Do you have any other serious lung conditions like COPD?
  6. Have you smoked or used tobacco products in the last 6 months?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, your involvement would last for about 10 weeks. You would have several visits to the study clinic during this time. At these visits, doctors and nurses would perform various checks, including assessing your asthma symptoms, taking measurements of your breathing, and possibly blood tests. You would be given specific inhalers to use daily, which would either contain the new combination medicine, one of the medicines on its own, or a dummy inhaler (placebo). You might also be asked to keep a diary of your symptoms and how you're feeling. Throughout the study, the research team will monitor your health closely.

Potential risks and benefits

Participating in a study like this may offer potential benefits, such as receiving a new asthma treatment under close medical supervision and contributing to the advancement of asthma care. However, there are also potential risks, including side effects from the study medication, which will be carefully monitored. You might also receive a placebo, meaning you wouldn't get the active study medicine. It is important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (175)

  • Teva Investigational Site 12087
    Verified postcode
    Phoenix, United States· Recruiting
  • Teva Investigational Site 12144
    Verified postcode
    Phoenix, United States· Completed
  • Teva Investigational Site 12104
    Verified postcode
    Tucson, United States· Completed
  • Teva Investigational Site 12146
    Verified postcode
    Tucson, United States· Recruiting
  • Teva Investigational Site 12102
    Verified postcode
    Little Rock, United States· Recruiting
  • Teva Investigational Site 12154
    Verified postcode
    Encinitas, United States· Recruiting
  • Teva Investigational Site 12103
    Verified postcode
    Huntington Beach, United States· Recruiting
  • Teva Investigational Site 12068
    Verified postcode
    La Palma, United States· Recruiting
  • Teva Investigational Site 12152
    Verified postcode
    Laguna Niguel, United States· Recruiting
  • Teva Investigational Site 12145
    Verified postcode
    Long Beach, United States· Recruiting
  • Teva Investigational Site 12088
    Verified postcode
    Los Angeles, United States· Recruiting
  • Teva Investigational Site 12094
    Verified postcode
    Los Angeles, United States· Recruiting

Common questions

What is a 'placebo' in a study?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers understand if the new medicine is truly effective.

What does 'double-blind' mean?

Double-blind means that neither you nor the study doctors will know whether you are receiving the new medicine, an existing medicine, or the placebo. This helps make the study results fair.

Will I still use my usual asthma medicines?

The study will provide specific instructions about which medicines to use. You will likely continue using your rescue inhaler if needed, but your daily asthma medicine routine might change for the study period. This will be explained in detail.

How long will the study last for me?

If you take part, your involvement in the study will be for approximately 10 weeks.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time, for any reason. Your decision will not affect your future medical care.

How to find out more

Teva U.S. Medical Information

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Randomized, Double-Blind, Placebo-Controlled Trial on Effi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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