Active not recruitingOBSERVATIONAL

Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]

The CHRONICLES study is investigating how a new triple inhaler treatment, Budenoside/Glycopyrronium/Formoterol (BGF), impacts people living with Chronic Obstructive Pulmonary Disease (COPD). It's a real-world study, meaning it looks at how patients use the medication in their regular daily lives, rather than in a strict research environment. Over six months, researchers will observe changes in their COPD symptoms, their general quality of life, and how often they experience sudden flare-ups (exacerbations). This helps understand the practical benefits of this treatment option for people like you. The study is being carried out in clinics in Ontario, Canada, and involves patients aged 35 and older with an existing COPD diagnosis who are starting this new medication.

At a glance

Status

Active not recruiting

Sponsor

AstraZeneca

Enrolment target

152

Start

17 Sep 2024

Estimated completion

31 Jul 2026

Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

This study, called CHRONICLES, is looking into a new inhaler treatment for Chronic Obstructive Pulmonary Disease (COPD). The inhaler, which contains three medicines (Budenoside, Glycopyrronium, and Formoterol, or BGF for short), is already available and used by patients. This research wants to see how people with COPD feel and function after starting this specific triple inhaler in their day-to-day lives.

Over a period of six months, the study will check for changes in several important areas. Researchers will be looking at how your COPD symptoms change – for example, if you find it easier to breathe. They will also assess your overall quality of life, which means things like how well you can do your daily activities, your energy levels, and your general well-being. Finally, they will track how often you experience 'exacerbations', which are sudden flare-ups or worsening of your COPD symptoms that might require extra treatment.

This is not a traditional drug trial where some people get the new drug and others get a dummy drug. Instead, it's an 'observational' study. This means researchers are simply observing what happens when doctors prescribe BGF to suitable patients in their usual clinics. The study aims to provide a clearer picture of how this medication helps people with COPD in a real-world setting, rather than in a controlled research environment.

Key takeaways

This study looks at a common COPD inhaler (BGF) in real-world use.
It aims to understand changes in COPD symptoms, quality of life, and flare-ups.
You participate if your doctor has already prescribed BGF for you.
The study lasts for six months after you start the treatment.
It helps us learn how this treatment works for everyday patients.
Participation involves sharing routine health information.

Who may be eligible?

To be considered for this study, you would need to be an adult aged 35 or older with a definite diagnosis of COPD from your doctor. You also need to be a patient within the Best Care Network and score 10 or more on a specific questionnaire called the CAT score, which measures the impact of COPD on your life. Importantly, you would be joining because your doctor has already decided to start you on the BGF inhaler as part of your standard care, and you agree to take it.

There are also some reasons why you wouldn't be able to join. For example, if you have asthma, dementia that affects your memory, or if you can't use an inhaler properly. You also can't have been in another study for COPD medication recently, had a COPD flare-up requiring hospitalisation in the last month, or be currently pregnant or breastfeeding. Also, if you've recently had COVID-19 or been hospitalised for it, you wouldn't be eligible.

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.

I am 35 years old or older.
My doctor has diagnosed me with COPD.
I have been told I am in the 'Best Care Network' for COPD.
My doctor has decided to start me on the BGF inhaler, and I agree.
I can read English.
I haven't been hospitalised for a COPD flare-up in the last month.

Answer every question to see your result.

What does participation involve?

If you join the CHRONICLES study, you will simply continue with your usual medical appointments. The key difference is that your doctor has already decided, with your agreement, to start you on the BGF inhaler as part of your regular treatment for COPD. The study then involves observing your progress for up to six months after you begin using this inhaler. You won't be given any experimental medication; you'll be using the inhaler prescribed by your doctor. The study will track changes in your symptoms, quality of life, and any COPD flare-ups during this time. This is done by collecting information from your routine clinic visits. You'll need to be able to read English to understand the study information and give your permission to be involved.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of how the BGF inhaler helps people with COPD in everyday life, which can benefit future patients. Since you're receiving a treatment your doctor has already decided is right for you, there are no additional drug-related risks beyond those associated with the BGF inhaler itself, which your doctor would have discussed with you. The primary 'risk' is the time involved in allowing your routine health information to be collected for the study. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Research Site
Verified postcode
Windsor, Canada

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, and it's a group of lung conditions that make it hard to breathe. It usually includes emphysema and chronic bronchitis.

What is the BGF inhaler?

BGF stands for Budenoside/Glycopyrronium/Formoterol. It's a type of inhaler that contains three different medicines to help manage COPD symptoms and reduce flare-ups.

Will I get a new medicine if I join?

No, you will only be included if your doctor has already decided to start you on the BGF inhaler as part of your regular care, so you'll be using an approved treatment.

How long will the study last for me?

The study will observe you for up to six months after you start using the BGF inhaler.

Do I have to do anything extra?

You'll attend your usual doctor's appointments. The study will mainly involve collecting information from these routine visits to see how you are doing.