← Back to Search

Unknown

BI 1291583 for Bronchiectasis

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP.
History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: at least 2 exacerbations, or at least 1 exacerbation and a St. George´s Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening visit 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 48
Awards & highlights

Study Summary

This trial is testing a new medication to see if it helps people with bronchiectasis.

Who is the study for?
Adults aged 18-85 with bronchiectasis, who produce sputum and have had flare-ups requiring antibiotics can join this study. They must use effective contraception if of childbearing potential. Excluded are those with certain other diseases like Cystic Fibrosis or immune deficiencies, severe liver disease, recent infections, or uncontrolled medical conditions.Check my eligibility
What is being tested?
The trial is testing the effectiveness of BI 1291583 in different doses compared to a placebo for treating bronchiectasis. Participants will be randomly assigned to one of four groups and take tablets daily for 6 months to a year while their health and flare-up frequency are monitored.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants' health will be closely watched for any unwanted effects from BI 1291583 or the placebo during visits and phone calls throughout the study period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I will use contraception if my partner can become pregnant.
Select...
I've needed antibiotics for lung problems at least twice last year or once with a high symptoms score.
Select...
I have been diagnosed with bronchiectasis and have symptoms like coughing and frequent infections.
Select...
I can produce sputum naturally and have a history of chronic coughing up of mucus.
Select...
I've had at least one lung infection flare-up since starting my long-term antibiotics.
Select...
I am between 18 and 85 years old (19 in Korea).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first pulmonary exacerbation up to 48 weeks after first drug administration
Secondary outcome measures
Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration
Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) Symptoms score at week 24 after first drug administration
Absolute change from baseline in percent predicted post-bronchodilator forced expiratory volume in one second (FEV1%pred) at week 24 after first drug administration
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 1291583: Medium dose groupExperimental Treatment1 Intervention
Group II: BI 1291583: Low dose groupExperimental Treatment1 Intervention
Group III: BI 1291583: High dose groupExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1291583
2019
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,339,970 Total Patients Enrolled
3 Trials studying Bronchiectasis
251 Patients Enrolled for Bronchiectasis

Media Library

BI 1291583 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05238675 — Phase 2
Bronchiectasis Research Study Groups: BI 1291583: Low dose group, BI 1291583: Medium dose group, BI 1291583: High dose group, Placebo
Bronchiectasis Clinical Trial 2023: BI 1291583 Highlights & Side Effects. Trial Name: NCT05238675 — Phase 2
BI 1291583 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05238675 — Phase 2
Bronchiectasis Patient Testimony for trial: Trial Name: NCT05238675 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a closed or open-label study?

"That is correct. The clinical trial in question, which was initially posted on March 21st, 2022, is still recruiting patients as of November 14th, 2022. There are a total of 240 patients that need to be enrolled from 17 different locations."

Answered by AI

Has BI 1291583 received the green light from the FDA?

"BI 1291583 falls into the category of a Phase 2 trial, where there is some evidence suggesting BI 1291583 is safe, but no data to support if it is effective. Therefore, our team has given it a score of 2."

Answered by AI

Who would be a good candidate to sign up for this experiment?

"This trial is open to patients aged 18-85 who have bronchiectasis. Male and female patients are eligible, though women of childbearing potential must adhere to contraception requirements. Patients must also meet the following criteria: - Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation., Age of patients when signing the informed consent ≥18 (for Korea: ≥19) and ≤85 years., Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator confirmed diagnosis of bronchiect"

Answered by AI

How many people will be participating in this clinical trial at most?

"That is correct. The clinical trial, which was originally posted on March 21st, 2022 is still recruiting patients according to information found on clinicaltrials.gov. There are currently 17 locations enrolling patients and the goal is to have 240 people enrolled in total."

Answered by AI

How many different medical facilities are overseeing this clinical trial?

"If you enroll in this study, it is worth noting that there are 17 sites across the country recruiting patients. The locations of these sites include Charleston, Jacksonville, Jasper and 14 other cities. To limit travel, it may be best to select the site closest to your location."

Answered by AI

Is this research open to people who are over 50 years old?

"Patients that want to enroll in this trial must be between 18 and 85 years old. However, there are 2 other studies for minors and 36 additional trials for senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
California
Louisiana
How old are they?
18 - 65
What site did they apply to?
Newport Native MD, Inc
Diagnostics Research Group
University of Kansas Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I tried a antibiotics to inhale but couldn’t take it.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. University of Kansas Medical Center: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
2022. "A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05238675.
All > Bronchiectasis
~0 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top