← Back to Search

Other

BI 1291583 group for Bronchiectasis

Phase 2

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening visit 1. For patients on stable oral or inhaled antibiotics as chronic treatment for BE, at least one exacerbation must have occurred while on stable antibiotics.

Historical clinical diagnosis of Cystic fibrosis (CF) (symptoms of CF and sweat chloride ≥ 60 mmol/L and/or 2 CF-causing Cystic fibrosis transmembrane conductance regulator (CFTR) mutations)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 weeks

Awards & highlights

Study Summary

This trial is recruiting adults with cystic fibrosis bronchiectasis to see if a new medicine, BI 1291583, is safe for them to take. Participants will be randomly assigned to

Who is the study for?

Adults over 18 with cystic fibrosis bronchiectasis can join this study. They must have a confirmed diagnosis, experience symptoms like coughing and frequent lung infections, and have had at least two flare-ups or one plus severe symptoms recently. Stable on antibiotics but still having flare-ups is okay.Check my eligibility

What is being tested?

The trial tests BI 1291583's tolerability in people with cystic fibrosis bronchiectasis. Participants are randomly assigned to either the test drug or placebo group, taking one tablet daily for 12 weeks. The test group has double the participants compared to the placebo.See study design

What are the potential side effects?

Potential side effects of BI 1291583 aren't specified here, but doctors will monitor health issues that could be related to the medication during seven visits over six months.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I've needed antibiotics for lung issues at least twice last year or once with a high SGRQ score.

Select...

I have been diagnosed with Cystic Fibrosis based on symptoms, sweat chloride test, or genetic testing.

Select...

I am 18 years old or older.

Select...

I have been diagnosed with Bronchiectasis based on a CT scan and my symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Treatment emergent Adverse Events (TEAEs) up to 16 weeks from first drug administration

Secondary outcome measures

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss)

Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval (AUCτ) for the first dose

Maximum measured concentration of the analyte in plasma (Cmax) at steady state (Cmax,ss)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 1291583 groupExperimental Treatment1 Intervention

Group II: Placebo groupPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 1291583

2019

Completed Phase 1

~100

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,883 Total Patients Enrolled

3 Trials studying Bronchiectasis

549 Patients Enrolled for Bronchiectasis

Frequently Asked Questions

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

Are participants currently being recruited for this study?

"According to clinicaltrials.gov, this research study is in the active recruitment phase. The trial was first posted on January 31st, 2024 and last revised on February 13th, 2024."

Answered by AI

What is the current number of participants being enlisted for this clinical trial?

"Indeed, the details on clinicaltrials.gov highlight that this medical investigation is presently seeking volunteers. It was initially shared on January 31st, 2024 and last revised on February 13th, 2024. The study aims to enroll 24 participants at one designated site."

Answered by AI

What is the potential harm of the BI 1291583 compound for individuals undergoing treatment?

"Based on the Phase 2 nature of this trial, our team at Power rates the safety profile of the BI 1291583 group as a 2. This indicates that while some safety data exists, efficacy data is lacking at this stage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

2024. "A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05865886.

All > Bronchiectasis > Cystic Fibrosis