Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma
This research study is investigating a medicine called dupilumab for adults who have moderate to severe asthma that isn't fully controlled by their current treatment. The main goal is to see if dupilumab can help prevent or slow down the natural decline in lung function that can happen with asthma over many years. Researchers want to compare dupilumab to the usual asthma care to understand its long-term benefits. This is a large, carefully designed study where some participants will receive dupilumab and others will receive a placebo (a dummy medicine), alongside their regular asthma treatment. Participants won't know which they are receiving. The study aims to provide important information about managing asthma effectively to protect lung health over time.
At a glance
What is this study about?
Asthma is a common lung condition that can make breathing difficult. For some people, especially those with moderate to severe asthma, their lung function can slowly get worse over time, even with regular treatment. This study wants to find out if a specific medicine, dupilumab, can make a difference in preventing this decline.
Dupilumab is already approved for treating severe asthma in some cases. However, this study, called a Phase 3b/4 study, is specifically designed to look at its long-term effects on how well your lungs work. Researchers will follow a group of adults with uncontrolled moderate to severe asthma for several years to see if those taking dupilumab experience less decline in their lung function compared to those receiving standard care.
The findings from this study are very important. If dupilumab can significantly reduce the worsening of lung function over time, it could help many people with asthma maintain their quality of life and breathe more easily for longer. It's about finding better ways to manage asthma and protect your lungs in the long run.
Key takeaways
- This study evaluates dupilumab for long-term asthma lung function.
- It targets adults with moderate to severe, uncontrolled asthma.
- Participants will receive either dupilumab or a placebo, plus their usual care.
- The main treatment period is 3 years, with close medical monitoring.
- The study aims to see if dupilumab can prevent lung function decline.
- Participation requires being at least 18 years old and meeting specific asthma criteria.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old, and have been diagnosed with asthma for at least a year. Your asthma should be classed as moderate to severe and not fully controlled by your current medication.
You must be taking specific asthma medications already, specifically a medium to high dose of an inhaled steroid combined with another control medicine, like a long-acting bronchodilator. You might also be taking a third controller medicine. All these medications need to have been at a stable dose for at least one month before the study begins.
Before you can officially join, several tests will be done to check your lung function and asthma control. For example, your lung power (measured by how much air you can forcefully breathe out in one second) needs to be below a certain level. You'll also need to score above a particular level on an asthma control questionnaire, indicating your asthma is not fully controlled. There will also be tests to confirm your airways react in a way typical for asthma, showing that your airflow varies.
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 for at least 12 months?
- Do you take medium to high dose inhaled steroids plus other controller medicines for your asthma?
- Does your asthma still feel uncontrolled, despite your current medicines?
- Do you have results from lung function tests that show your lung power is below normal?
- Have tests shown that your airways react in a way typical for asthma (e.g., variable airflow)?
What does participation involve?
If you decide to take part, the study will last quite a while. First, there's a screening period of about 4 to 5 weeks to ensure you meet all the requirements. After that, you'll enter the main treatment period, which will last for 3 years. During this time, you will receive either dupilumab or a placebo (a dummy medicine) along with your regular asthma treatment. Neither you nor your study doctor will know which you are receiving – this is called a 'double-blind' study.
You'll have regular visits to the clinic for assessments, which will include lung function tests, questionnaires, and possibly blood tests to monitor your health and how your asthma is responding. After the 3-year treatment period, there will be a follow-up period of up to 12 weeks to see how you are doing after stopping the study medication.
Potential risks and benefits
Locations (249)
- Cullman Research Center- Site Number : 8400001Verified postcodeCullman, United States
- Shoals Primary Care - Sheffield- Site Number : 8400015Verified postcodeSheffield, United States
- Chandler Clinical Research Trials- Site Number : 8400147Verified postcodeChandler, United States
- Pulmonary Associates - Deer Valley Office- Site Number : 8400155Verified postcodePhoenix, United States
- Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130Verified postcodePhoenix, United States
- Del Sol Research Management - Tucson- Site Number : 8400017Verified postcodeTucson, United States
- Kern Allergy and Medical Research- Site Number : 8400037Verified postcodeBakersfield, United States
- Vitality Clinical Research- Site Number : 8400142Verified postcodeBeverly Hills, United States
- Ascada Research - Fullerton- Site Number : 8400076Verified postcodeFullerton, United States
- Allergy and Asthma Specialists Medical Group- Site Number : 8400162Verified postcodeHuntington Beach, United States
- Newport Native MD- Site Number : 8400054Verified postcodeNewport Beach, United States
- Prospective Research Innovations- Site Number : 8400131Verified postcodeRancho Cucamonga, United States
Common questions
What is dupilumab?
Dupilumab is a type of medicine that targets specific parts of your immune system to help reduce inflammation, which is often a problem in people with certain types of asthma.
What is a 'placebo'?
A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects against no specific treatment.
Will I still take my regular asthma medicine?
Yes, you will continue to take your usual asthma medications throughout the study, as dupilumab is given in addition to standard care.
How long will the study last?
The entire study involves a screening period of about a month, a treatment period of 3 years, and a follow-up period of up to 12 weeks after treatment ends.
Who will know if I'm getting the real medicine or the placebo?
Neither you nor your study doctor will know. This is a common way to conduct research to make sure the results are as unbiased as possible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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