A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® pressurised MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS)
This research study, called KALOS, is looking for adult and adolescent patients whose asthma isn't fully controlled by their current treatment. The main goal is to find out if a new inhaler, which contains three different medicines (budesonide, glycopyrronium, and formoterol fumarate), is better and safer than the inhalers currently available. Researchers want to see if this new inhaler can help improve breathing, prevent serious asthma flare-ups (exacerbations), and improve daily life for people with asthma. The study will last between 24 and 52 weeks and involves different groups of patients receiving either the new inhaler, an existing combination inhaler, or a matching placebo.
At a glance
What is this study about?
Imagine you have asthma, and even with your current treatment, you still find it hard to breathe sometimes, or you have flare-ups that send you to the doctor or hospital. This study, called KALOS, is for people just like you – adults and teenagers (aged 18 and over) whose asthma isn't fully under control.
The main aim is to test a new inhaler. This new inhaler has three different medicines in it, compared to some current inhalers which have two. The study wants to see if this `triple` inhaler is more effective at helping people breathe better and preventing serious asthma attacks, compared to the combination inhaler that many people use now, called Symbicort, or another similar one. Researchers also want to make sure the new inhaler is safe to use.
To make sure the results are fair and accurate, the study is designed very carefully. Some people will get the new inhaler, some will get a standard two-medicine inhaler, and some will get an inhaler that looks the same but contains no active medicine (a placebo). Neither you nor your study doctor will know which one you are getting – this is called "double-blind" and helps avoid any bias. Researchers will measure how much your breathing improves and how often you have asthma attacks over a period of 24 to 52 weeks.
Key takeaways
- Tests a new triple-medicine inhaler for adults with asthma.
- Compares it to existing dual-medicine inhalers and a dummy inhaler.
- Aims to improve breathing and reduce asthma attacks.
- Study lasts between 24 and 52 weeks.
- Participants receive free medical care and study medication.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender, who have asthma that isn't fully controlled by their current medication. Simply put, if your asthma still bothers you quite a bit, even when you're taking your usual medicines, you might be suitable.
It's important to remember that 'inadequately controlled asthma' means that despite using your regular inhalers, you still experience symptoms like wheezing, shortness of breath, chest tightness, or coughing, or you've had asthma attacks. The study doctors will carefully check your medical history to make sure the study is a good fit for you and that it's safe for you to participate.
There will also be other specific health requirements or conditions that might mean you can't join, for example, if you have certain other medical problems or are taking particular medications. The study team will discuss all these details with you during your initial visit.
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 asthma?
- Do you feel your asthma isn't fully controlled by your current inhalers?
- Are you able to attend regular study visits over several months?
What does participation involve?
If you decide to take part in this study, it will last between 24 and 52 weeks. You'll be given one of the study inhalers to use daily – either the new triple-medicine one, a standard two-medicine one, or a dummy inhaler (placebo). You won't know which one you're getting, nor will your study doctor.
You'll have several visits to the study clinic throughout the trial. During these visits, doctors will check your breathing using a special test called FEV1, where you breathe out into a machine. They'll also ask you about your asthma symptoms, how you're feeling generally, and if you've had any asthma attacks. You will also use relief inhalers like Salbutamol if needed. The study team will explain everything in detail, including how and when to use your inhaler, what to do if you have symptoms, and how to keep track of them.
Potential risks and benefits
Locations (6)
- —UnverifiedSpain
- —UnverifiedRomania
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedPoland
Common questions
What is the new inhaler being tested?
It's an inhaler with three different medicines: budesonide, glycopyrronium, and formoterol fumarate, designed potentially to help with asthma that isn't well controlled.
How long will the study last if I join?
The study will last for a period between 24 weeks (about 6 months) and 52 weeks (about a year).
Will I know if I'm getting the new medicine or a dummy inhaler?
No, neither you nor your study doctor will know which inhaler you receive. This is standard in research to ensure fair results.
What does 'inadequately controlled asthma' mean?
It means your asthma symptoms-like coughing, wheezing, or breathlessness-still bother you sometimes, or you’ve had flare-ups, even when using your usual asthma medicines.
What will happen during my study visits?
At visits, doctors will check your breathing, ask about your asthma symptoms, and monitor your general health and any side effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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