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Clinical Trial Finder
Anti-Inflammatory Closed to Enrollment
Study to evaluate BI 1291583 in adults with cystic fibrosis bronchiectasis. (Clairafly) (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.
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 more information about the results of this study and where it was conducted, 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
Boehringer Ingelheim -
Study Drugs:
Study Sites
-
Closed to Enrollment
California
University of California at Davis Medical Center, Sacramento, CA 95817
-
Closed to Enrollment
Colorado
National Jewish Health, Denver, CO 80206
-
Closed to Enrollment
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
-
Closed to Enrollment
New York
Lenox Hill Cystic Fibrosis Center, New York, NY 10028
-
Closed to Enrollment
Texas
University of Texas Health Center at Tyler, Tyler, TX 75708
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 more information about the results of this study and where it was conducted, 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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