CatC inhibitor Phase II in bronchiectasis
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis
IRAS ID
1004444
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2021-003304-41
Clinicaltrials.gov Identifier
Research summary
Research Summary
This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day. Participants are in the study for between 6 months and 1 year. During this time, they visit the
study site about 10 times and get about 5 phone calls from the site staff. The doctors document when participants experience flare-ups during the study. The time to the first flare-up is compared between the treatment groups. Doctors also regularly check participants’ health and take note of any unwanted effects.Lay Summary of study results
This Lay Summary was developed with patients who were not involved in this clinical study. We thank all study participants. You helped us to answer important questions about BI 1291583 & the treatment of bronchiectasis. The purpose of this study was to find if a medicine called BI 1291583 helps people with bronchiectasis.
Bronchiectasis is a long-term lung disease that causes inflammation, widening & scarring of the airways. Symptoms include breathlessness, coughing & excess mucus production. People with bronchiectasis have frequent flare-ups. During flare-ups, symptoms get worse. This study compared 3 different doses of BI 1291583 to see if one of the doses would work better at preventing flare-ups.
Adults with bronchiectasis could join the study if they had a history of flare-ups & frequently produced excess mucus.
322 people took part in this study;191 women & 131 men.
Participants were aged between 18 and 85 years old. Participants were from 5 different ethnic groups. Participants from Black/African American & Hawaiian/Pacific Islander ethnic groups represented less than 1%. Most of the participants were from 3 ethnic groups: Asian (19%), American Indian/Alaskan Native (3%) & White (78%)
A computer randomly placed participants into four groups: low, medium, or high dose or placebo group. They were more likely to be in the high dose or placebo groups.
Participants took BI 1291583 or placebo tablets daily for at least 6 months & up to 1 year. Placebo tablets looked like BI 1291583 tablets but did not contain any medicine. Researchers compared the groups to find out how well different BI 1291583 doses work.
During the study, no one knew which group participants were placed in; including participants, study doctor, & researchers. This is because knowing which treatment a participant was getting might affect the results of the study. At the end of the study, the information about each participant’s treatment group was released.
Participants visited the study site regularly, where doctors monitored their health and recorded any issues, including bronchiectasis flare-ups.
The time to the first flare-up was compared between treatment groups.
The study showed that participants taking the medium & high doses of BI 1291583 had a lower risk of having a flare-up & had fewer flare-ups during the study.
Researchers decided to use the medium dose for further testing because the medium dose worked the same as the high dose at preventing flare-ups.
The rate of unwanted effects was about the same for all groups.
During the study, no one knew which group participants were placed in. Study doctors took note if participants had any unwanted effects that they thought were caused by the study medicine.
8 out of 53 participants (15%) in the BI 1291583 low dose group had unwanted effects. 9 out of 53 participants (17%) in the BI 1291583 medium dose group had unwanted effects. 18 out of 107 participants (17%) in the BI 1291583 high dose group had unwanted effects. 16 out of 109 participants (15%) in the placebo group had unwanted effects.
The most common unwanted effects were shedding of the skin & headache.
1 participant in the low dose group had a serious unwanted effect that the study doctor thought was caused by the study medicine. The serious unwanted effect was a tear in the retina of the eye. The retina is the light-sensitive tissue at the back of the eye. The participant recovered without stopping the study medicine.
The study took place in 22 countries across the world. Participants were divided into 3 different regions. The following listing shows the number of participants in the study in different countries; Germany (36) Denmark (15) Spain (12), France (8) Netherlands (8) Italy (6) Belgium (5), United Kingdom (3) Portugal (2) United States (35) Mexico (19) Canada (4) Australia (25) Israel (5) Latvia (24) Hungary (20) Bulgaria (17) Pol& (17) Turkey (6) Czechia (3) Japan (32) Korea (20)
You can find further information about this study at these websites:www.mystudywindow.com/completed search for the study number 1397-0012.
www.clinicaltrialsregister.eu/ctr-search search for the EudraCT number 2021-003304-41.
www.clinicaltrials.gov search for the NCT number 05238675.
Boehringer Ingelheim sponsored this study. For contact details, please visit www.boehringer-ingelheim.com/contact-us.
Study Title: A randomised double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety & tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf™)
Study started in April 2022 & finished in May 2024.
If we do more clinical studies with BI 1291583, you will find them on the websites listed above. To search for these studies, use BI 1291583.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0072
Date of REC Opinion
5 May 2022
REC opinion
Further Information Favourable Opinion