Ongoing, recruitingTherapeutic use (Phase IV)Interventional

THE ANTES B+ STUDY: AN OPEN-LABEL, PRAGMATIC, RANDOMIZED, CONTROLLED TRIAL OF TRIPLE THERAPY VERSUS LABA-LAMA COMBINATION TO IMPROVE CLINICAL CONTROL IN HIGH-RISK GOLD B PATIENTS (B+)

This research study, called ANTES B+, is looking into how effective different inhalers are for people living with Chronic Obstructive Pulmonary Disease (COPD). Specifically, it compares a newer inhaler called Trelegy, which contains three medicines, with inhalers that combine two medicines (known as LABA-LAMA treatments). The main goal is to find out if Trelegy helps patients with COPD to manage their symptoms and keep their condition more stable over a 12-month period. Researchers will check regularly to see if patients are feeling better and experiencing fewer flare-ups. This could help doctors decide the best treatment for people with COPD who are at higher risk of their condition worsening.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio Privada Mon Clinic Barcelona

Enrolment target

1,028

Start

22 Nov 2023

Chronic Obstructive Pulmonary Disease

What is this study about?

This study, called ANTES B+, is designed to help us understand the best ways to treat adults living with a lung condition called Chronic Obstructive Pulmonary Disease (COPD). COPD can make it difficult to breathe and often involves symptoms like coughing, wheezing, and breathlessness.

The main aim of this study is to compare two types of inhaler treatments. One is a newer inhaler called Trelegy, which contains three different medicines to help improve breathing. The other type of treatment involves inhalers that combine two medicines (often called LABA-LAMA treatments). Researchers want to see if Trelegy helps people with COPD keep their symptoms under better control for a longer time, specifically over a year.

To do this, patients in the study will be split into groups, and each group will receive a different treatment. Throughout the study, doctors will regularly check how well each patient's COPD is managed. This includes looking at their overall health, how often they have flare-ups (when their symptoms get much worse), and how their breathing affects their daily life. The results from this study could help doctors make more informed decisions about which inhaler treatments work best for people with COPD, especially those who are at a higher risk of their condition getting worse.

Key takeaways

The study compares a three-in-one inhaler (Trelegy) with two-in-one inhalers for COPD.
It aims to see which treatment helps control COPD symptoms better over a year.
Participants will have regular check-ups to monitor their breathing and overall health.
It's for adults aged 18 and over with COPD.
Results could help doctors choose the best COPD treatments in the future.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older, who has been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

There will also be other specific health requirements that only a study doctor can check. These might include how severe your COPD is, what other health conditions you have, and what other medications you are currently taking. It's important for the researchers to make sure everyone in the study meets certain criteria so that the results are clear and helpful.

Both men and women are welcome to take part. If you're interested, the study team will go through all the details with you to see if the study is a good fit and safe for you.

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 Chronic Obstructive Pulmonary Disease (COPD)?
Are you currently receiving treatment for your COPD?
Are you able to attend regular clinic appointments for one year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the Trelegy inhaler or a standard LABA-LAMA inhaler combination, as decided by chance (like flipping a coin). You would use this inhaler as instructed by the study team. You would also have regular check-ups at a clinic over a 12-month period. These visits would involve discussing your symptoms, how you're feeling, and potentially some breathing tests or questionnaires to assess your health and how well your COPD is controlled. The total duration of your active participation in the study would be one year.

Potential risks and benefits

Participating in this study might offer you access to a new treatment option for COPD and close monitoring of your health by medical professionals. However, like all medications, the inhalers used in the study can have side effects, and some might be unpleasant or unexpected. The study team will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Spain

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, a common lung disease that makes it hard to breathe and causes coughing and wheezing.

What is Trelegy?

Trelegy is an inhaler that contains three different medicines to help open up your airways and make breathing easier for people with COPD.

What are LABA-LAMA treatments?

LABA-LAMA treatments are inhalers that combine two different medicines, both designed to help relax the muscles around your airways to improve breathing.

How long will the study last?

If you join the study, your active participation and check-ups will last for one year.

Will I know which treatment I'm getting?

This study is 'open-label,' which means you and your study doctor will know which inhaler treatment you are receiving.