Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Triple therapy effectiveness in COPD patients with characteristics of asthma: A pragmatic primary care trial - The TRACkER trial

This research, called the TRACkER trial, is looking into the best ways to treat Chronic Obstructive Pulmonary Disease (COPD), especially for people who also show signs of asthma. The main goal is to find out if using a single inhaler that contains three different medicines (called 'triple therapy') helps people feel better and improves their health more than using inhalers with just two medicines. Researchers will compare how patients feel at the end of 26 weeks of treatment by looking at changes in their health status. This study is aimed at improving real-world care for COPD patients in general practice settings.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

General Practitioners Research Institute B.V.

Enrolment target

316

Start

24 Oct 2023

Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

Imagine you have COPD, but you also sometimes feel like you have asthma. Doctors are always looking for the best ways to help people like you breathe easier and feel healthier. This study, called the TRACkER trial, is trying to answer a very important question: for people with COPD who also have some asthma-like symptoms, does a new type of inhaler work better than what they might be using now?

Currently, many people with COPD use inhalers with two different medicines combined. This trial is looking at 'triple therapy,' which means an inhaler that has three different medicines in one. The researchers want to see if this triple therapy helps people feel significantly better – improving their daily life and general health more than the two-medicine inhalers. This is a "real-world" study, meaning it's happening in regular GP practices, not just in hospitals.

The main aim is to carefully compare how people feel and how their health changes after using either the triple therapy or one of the two-medicine inhalers for about six months. By doing this, doctors hope to understand if triple therapy should become a more common way to treat COPD patients who have these mixed symptoms, ultimately leading to better care for you.

Key takeaways

The study helps us understand the best inhaler treatments for COPD patients with asthma-like symptoms.
It compares a new 'triple therapy' inhaler with current two-medicine inhalers.
The main goal is to see if triple therapy helps people feel healthier and breathe better.
This research takes place in local GP practices, making it relevant to everyday care.
Participation lasts about six months and involves regular health checks.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women. You must also have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD).

If you have COPD and your doctor thinks you might have some asthma-like features, this study could be for you. The researchers are specifically interested in how different treatments work for this group of patients.

Your doctor will be able to tell you if you meet all the specific requirements to join. It’s important to discuss your full medical history with them to see if this study is suitable for you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)?
Are you open to trying a different inhaler treatment?
Are you able to attend regular check-ups with your doctor or research nurse?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have a meeting with your doctor or research nurse to make sure it's right for you. They would then tell you which inhaler treatment you would be trying – either a three-in-one inhaler (triple therapy) or one of the two-in-one inhalers that are already widely used. You would use this new treatment for about 26 weeks, which is roughly six months.

Throughout these six months, you would likely have a few appointments where the research team would check on your health and how you're feeling. This might include answering questionnaires about your breathing and overall well-being. They will be looking to see if your health has improved in a way that makes a real difference to your daily life. After the 26-week period, there would be a final check-up to assess the overall effects of the treatment.

Potential risks and benefits

Taking part in this trial could offer several potential benefits. You might receive a new treatment that could improve your breathing and overall health more than your current medication, especially if you have COPD with asthma-like symptoms. You'll also be closely monitored by medical professionals, which can be reassuring. On the other hand, there might be some risks, just like with any medication, such as potential side effects from the inhalers. These would be fully explained to you before you start. It’s important to remember that you are a volunteer; you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What is COPD?

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

What does 'triple therapy' mean?

'Triple therapy' refers to an inhaler that combines three different medicines into one device, aimed at improving breathing.

Will I know which treatment I'm getting?

Yes, in this study, your doctor will know which type of inhaler you are prescribed, either triple therapy or a two-medicine inhaler.

How long does the study last for me?

If you join, you would be taking the study treatment and having check-ups for about 26 weeks, which is roughly six months.

Can I leave the study if I want to?

Yes, you are completely free to leave the study at any point, and your decision won't affect your medical care.