The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
The AIRTIVITY™ study is exploring a new medicine called BI 1291583 to help people aged 12 and above who have bronchiectasis and experience flare-ups. Participants will be randomly given either the new medicine or a dummy tablet (placebo) that looks the same but contains no active drug. They will take one tablet daily for up to 18 months. Throughout the study, which lasts up to 20 months in total, participants will have regular check-ups at the clinic and phone calls. They'll also record their symptoms using a smartphone. The main goal is to compare how many flare-ups occur in people taking the new medicine versus those taking the placebo, and to monitor any side effects.
At a glance
What is this study about?
Bronchiectasis is a long-term lung condition where your airways become damaged and wider, making it harder to clear mucus and leading to infections and inflammation. This can cause repeated chest infections, known as flare-ups or exacerbations, which often require antibiotics.
This study, called AIRTIVITY, is designed to see if a new potential medicine, known as BI 1291583, can help people with bronchiectasis. Specifically, researchers want to find out if this medicine can reduce the number of flare-ups that people experience. If it proves effective, it could offer a new treatment option to help manage the condition.
To ensure fair results, some participants will receive the new medicine and others will receive a placebo – a tablet that looks identical but contains no medicine. This allows doctors to accurately compare the effects of the new drug against not having it, helping them understand if BI 1291583 truly makes a difference. All participants, regardless of which tablet they receive, will be carefully Monitored by the study team.
Key takeaways
- This study is testing a new medicine for bronchiectasis to see if it reduces flare-ups.
- It's for people aged 12 and over who have bronchiectasis and produce mucus and have had flare-ups.
- Participants will take a tablet daily for up to 18 months, either the new medicine or a placebo.
- You'll have regular clinic visits and phone calls, and track symptoms on a smartphone.
- The study helps doctors understand if the new medicine is safe and effective.
Who may be eligible?
This study is open to both adults and teenagers aged 12 and older who have been diagnosed with bronchiectasis. For teenagers aged 12 to under 18, they must weigh at least 35 kilograms (about 5 stone 7 pounds).
To join, you need to produce mucus (sputum) and have a history of flare-ups (exacerbations) that required antibiotic treatment. Specifically, in the year before the study starts, you must have had at least two flare-ups, or one flare-up along with significant symptoms. Doctors will look at your past scans or arrange a new scan to confirm your bronchiectasis diagnosis.
There are also other specific health requirements that your study doctor will discuss with you to make sure the study is a good fit and safe for you. Women who could become pregnant will need to use effective birth control methods during the study.
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 12 years old or older?
- Have you been diagnosed with bronchiectasis by a doctor?
- Do you produce mucus (sputum)?
- Have you had at least two bronchiectasis flare-ups in the last year, or one severe flare-up?
- Are you able to visit the study clinic regularly and use a smartphone for daily diaries?
What does participation involve?
If you decide to take part, you'll be in the study for up to 1 year and 8 months (20 months in total). During this time, you will visit the study clinic about 10 times. You'll also receive around 13 phone calls from the study staff to check in on you.
You will take one tablet every day for up to 1 year and 6 months – either the new medicine (BI 1291583) or a dummy tablet (placebo). You'll keep a daily diary on a smartphone to record any changes in your bronchiectasis symptoms. The study doctors will regularly check your overall health, note any flare-ups you have, and keep track of any unwanted effects from the tablets.
Potential risks and benefits
Locations (494)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States· Active not recruiting
- Providence Medical Group AlaskaVerified postcodeAnchorage, United States· Not yet recruiting
- Dignity Health, St. Joseph's Hospital and Medical CenterVerified postcodePhoenix, United States· Not yet recruiting
- University of ArizonaVerified postcodeTucson, United States· Recruiting
- Newport Native MD, IncVerified postcodeNewport Beach, United States· Recruiting
- Paradigm Clinical Research - ReddingVerified postcodeRedding, United States· Recruiting
- University of California DavisVerified postcodeSacramento, United States· Recruiting
- University of California San FranciscoVerified postcodeSan Francisco, United States· Recruiting
- Ventura County Medical CenterVerified postcodeVentura, United States· Not yet recruiting
- National Jewish HealthVerified postcodeDenver, United States· Recruiting
- Yale University School of MedicineVerified postcodeNorth Haven, United States· Recruiting
- Georgetown UniversityVerified postcodeWashington D.C., United States· Recruiting
Common questions
What is bronchiectasis?
Bronchiectasis is a long-term lung condition where the airways become widened and damaged, making it hard to clear mucus and leading to infections.
What is a 'flare-up' or 'exacerbation'?
A flare-up is when your bronchiectasis symptoms suddenly get worse, often requiring antibiotic treatment.
What is a placebo?
A placebo is a dummy tablet that looks exactly like the study medicine but doesn't contain any active drug. It helps compare the new medicine's effects fairly.
Will I know if I'm getting the real medicine or the placebo?
No, in this type of study, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps ensure unbiased results.
How long will I be involved in the study?
You'll be involved for up to 1 year and 8 months in total, which includes taking the study tablet for up to 1 year and 6 months.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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