Page Title
Clinical Trial Finder
Anti-Inflammatory Enrolling
Study to evaluate BI 1291583 in adults with cystic fibrosis bronchiectasis. (Boehringer Ingelheim BI1397-0013)
BI 1291583 is a potential therapy intended to reduce inflammation in the lungs of people with bronchiectasis, the progressive lung disease that occurs in cystic fibrosis and other conditions. This study will test the safety, tolerability, and the effect on the body of BI 1291583.
This study will be randomized, and placebo controlled. This means that some participants will receive BI 1291583 and some will receive a placebo. This is a double-blind study so neither the study participant, nor the research team will know whether the participant received the study drug. Researchers will measure safety and tolerability by monitoring for adverse events. They will also track how much of the study drug is in the blood.
This study may require blood testing and sputum collection.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either:
a. at least 2 exacerbations, or
b. at least 1 exacerbation and a SGRQ Symptoms score of >40 at screening visit 1.
Confirmed diagnosis by CT scan and clinical history consistent with bronchiectasis.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
22 weeks -
Number of Study Visits:
7
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
BI -
Study Drugs:
Study Sites
-
Enrolling Soon
California
University of California at Davis Medical Center, Sacramento, CA 95817
Contact
Daniel Diaz-Vigil
Phone: +1 (916) 734-8686
Email: ddiazvigil@ucdavis.edu
-
Enrolling Soon
Colorado
National Jewish Health, Denver, CO 80206
Contact
Alix Wilson
Phone: +1 (303) 270-2517
Email: wilsona@njhealth.org
-
Enrolling Soon
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
-
Enrolling Soon
New York
Lenox Hill Cystic Fibrosis Center, New York, NY 10028
Contact
Teresa Demarco
Phone: +1 (212) 434-4790
Email: Tdemarco3@northwell.edu
-
Enrolling Soon
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
-
Enrolling Soon
Texas
University of Texas Health Center at Tyler, Tyler, TX 75708
Contact
Debbie Fielder
Phone: +1 (903) 877-7753
Email: debbie.fielder@uthct.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either:
a. at least 2 exacerbations, or
b. at least 1 exacerbation and a SGRQ Symptoms score of >40 at screening visit 1.
Confirmed diagnosis by CT scan and clinical history consistent with bronchiectasis.
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