The AIRTIVITY™ Study: A study investigating an anti-inflammatory medicine in people with bronchiectasis, including those with and without cystic fibrosis

The AIRTIVITY™ Study: A study to find out whether a new anti-inflammatory medicine (BI 1291583) helps people with bronchiectasis, including those with and without cystic fibrosis

The study aims to find out whether a medication called BI 1291583 can help people with a lung condition called bronchiectasis. It will assess whether the medication can reduce the number of flare-ups (also called exacerbations) slow down worsening of lung function, and improve quality of life. 

This study includes people who have bronchiectasis, whether or not they have cystic fibrosis (CF). CF is a genetic condition that can lead to bronchiectasis, which is a long-term lung condition where the airways become widened and inflamed. In fact, bronchiectasis is the main way lung disease shows up in people with CF. Although CF accounts for only about 2% of all people with bronchiectasis, a considerate proportion of adults with CF develop bronchiectasis. Because of this, CF can be seen as a specific cause - or etiology - of bronchiectasis. 

This study aims to explore whether an anti-inflammatory medicine can help reduce symptoms and improve lung health in people with bronchiectasis, regardless of the underlying cause. 

People living with bronchiectasis who have had flare-ups needing antibiotic treatment in the past 12 months, may be able to take part. 

The study compares BI 1291583 with a placebo. A placebo looks like the medication but does not contain any active ingredients. 

Participants will receive either BI 1291583 or the placebo. This will be decided randomly (by chance, like drawing a number from a hat). The medication or placebo will be taken once a day. Neither participants nor the study doctors will know which one is taken. 

The study will last up to 20 months. During this time, participants will visit the study site up to 10 times and receive around 13 phone calls from the study team. Financial support for travel to the study site and inconvenience fees will be provided.

At each visit, the study doctor will review any changes in bronchiectasis symptoms. The number of flare-ups will be compared between those taking the study medication and those taking the placebo to find out if the medication help reduce flare-ups. 

Participants will be asked to: 

• Provide blood and sputum samples
• Undergo lung function investigations
• Answer questions about quality of life, symptoms, and cough
• Use a smartphone device to complete a daily electronic diary and two questionnaires

The study doctor will regularly check participants' health and monitor for any unwanted side effects.