A double-dummy, double-blind, randomized, active controlled, two-way cross-over study with 12-week treatment duration per period, to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.
This research study is investigating a new inhaler treatment for asthma called QVM149. It's designed for teenagers between 12 and 18 years old who have asthma. The study will compare QVM149 to existing inhalers to see how well it helps control asthma symptoms and improves lung function. Researchers will also be carefully checking for any side effects. Participants will receive different inhalers over two 12-week periods, with careful monitoring throughout. The main goal is to find out if this new medicine is an effective and safe option for young people with asthma, potentially offering a better way to manage their condition.
At a glance
What is this study about?
This study is a clinical trial looking into a new asthma medication called QVM149. It's specifically for young people with asthma, aged 12 to under 18 years old. The main aim is to see if this new inhaler works better than current treatments at helping teenagers breathe easier and control their asthma symptoms. We know asthma can be challenging, and finding new and effective ways to manage it is really important.
To figure this out, participants will try both the new medication (QVM149) and an existing asthma inhaler (like Salmeterol/Fluticasone, often known as Seretide or AirFluSal) at different times. Some people will also receive a 'placebo' inhaler, which looks the same but contains no active medicine. This helps researchers understand the true effect of each treatment. The study is very carefully designed so that neither the patient nor the doctor knows which treatment is being given at which time, making the results as fair and accurate as possible.
The researchers will be monitoring several things carefully. They'll regularly check how well people's lungs are working, specific asthma symptom scores, how much 'rescue' inhaler (like Ventolin) is needed, and how often asthma flare-ups occur. They'll also keep a close eye on any side effects to make sure the new treatment is safe.
Key takeaways
- This study is testing a new asthma inhaler (QVM149) for teenagers aged 12-18.
- It compares the new inhaler to existing treatments and a placebo.
- The main goals are to see if it improves breathing and reduces asthma symptoms.
- Participants will be closely monitored for safety and effectiveness.
- The study involves two 12-week treatment periods where different inhalers are used.
- Neither you nor your doctor will know which treatment you're using at any time.
Who may be eligible?
This study is specifically looking for teenagers who have asthma. To be considered for this study, you need to be aged between 12 and under 18 years old. Both boys and girls can take part.
There might be other health conditions or medications that would mean you couldn't join, as these studies need to be very precise. For example, if you have other serious health problems or are taking certain medicines, it could affect whether you're able to participate safely.
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 between 12 and 18 years old?
- Do you have a diagnosis of asthma?
- Are you able to use an inhaler as instructed?
- Do you understand that you might receive a placebo at some point?
- Are you willing to attend regular clinic visits?
What does participation involve?
If you decide to take part in this study, you would be involved in two treatment periods, each lasting 12 weeks. During these periods, you would use a specific inhaler – either the new study medication, a standard asthma inhaler, or a placebo inhaler. Neither you nor your study doctor would know which one you are taking at any given time.
Throughout the study, you would have regular visits to the clinic. At these visits, doctors and nurses will check your breathing, assess your asthma symptoms, ask about how you're feeling, and conduct tests like lung function measurements (using a device to measure how much air you can breathe out in one second – called FEV1). They will also ask about how often you use your rescue inhaler and if you've had any asthma flare-ups. There might also be blood tests and heart trace (ECG) checks to monitor your safety. After each 12-week treatment period, there will be a 'washout' period where you might stop the study inhaler for a short time before starting the next one. The total duration of your participation would involve these two 12-week periods plus any initial screening and follow-up.
Potential risks and benefits
Locations (4)
- —UnverifiedFrance
- —UnverifiedSlovakia
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What is an inhaler called QVM149?
QVM149 is a new investigational inhaler combining three different medicines in one, designed to help manage asthma.
What does 'double-blind' mean?
It means neither you nor your doctor will know which specific treatment you are receiving (the new medicine, a standard one, or a placebo), to ensure the results are fair.
What is a placebo?
A placebo is an inactive substance that looks exactly like the study medication but contains no active medicine. It helps researchers understand the true effect of the active drug.
Will I still use my rescue inhaler (like Ventolin)?
Yes, you will still have your rescue inhaler to use if you experience asthma symptoms and need quick relief.
How long will I be in the study?
You will participate in two treatment periods, each lasting 12 weeks, with breaks in between, plus initial checks and follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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