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Anti-Inflammatory Closed to Enrollment

Study to evaluate BI 1291583 in adults with bronchiectasis (BI 1397-0014 (Airtivity))

This study will test the effectiveness, safety, and tolerability of BI 1291583, a drug intended to reduce inflammation in the lungs.

 

This study is randomized and placebo controlled. This means participants will be placed in one of two groups by chance. Some participants will receive BI 1291583 and some will receive a placebo. Researchers will measure the drug’s effectiveness by tracking pulmonary symptoms and lung function testing. Researchers will also track for any side effects.

This study may require lung function tests, daily diaries, and/or other measurements.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    50 to 100%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Eligible participants will need to have had at least one pulmonary exacerbation requiring antibiotic treatment in the 12 months prior to enrollment. This study is enrolling both people with CF and people without CF that have bronchiectasis.  

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    76 weeks

  • Number of Study Visits:

    9

Additional Information

  • Phase: ?more info

    Phase Three

  • Study Sponsor: ?more info

    Boehringer Ingelheim

  • Study Drugs:

    Verducatib (BI-1291583)

Study Sites

  • Closed to Enrollment

    Alabama

    University of Alabama at Birmingham, Birmingham, AL 35233

  • Closed to Enrollment

    Alaska

    Providence Alaska Medical Center, Anchorage, AK 99508

  • Closed to Enrollment

    Arizona

    Tucson Cystic Fibrosis Center, Tucson, AZ 85719

  • 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

    Florida

    Central Florida Pulmonary Group, Orlando, FL 32803

  • Closed to Enrollment

    Illinois

    Northwestern University, Chicago, IL 60611

  • Closed to Enrollment

    Indiana

    Indiana University Medical Center, Indianapolis, IN 46202

  • Closed to Enrollment

    Kansas

    University of Kansas Medical Center, Kansas City, KS 66160

  • Closed to Enrollment

    Massachusetts

    Massachusetts General Hospital, Boston, MA 02114

  • Closed to Enrollment

    Michigan

    University of Michigan Health System, Ann Arbor, MI 48109

  • Closed to Enrollment

    Missouri

    SSM Health Saint Louis University Hospital, St. Louis, MO 63110

  • Closed to Enrollment

    Nebraska

    University of Nebraska Medical Center, Omaha, NE 68198

  • Closed to Enrollment

    New Hampshire

    Dartmouth Hitchcock Medical Center, Lebanon, NH 03756

  • Closed to Enrollment

    New Jersey

    Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ 08903

  • Closed to Enrollment

    New York

    Long Island Jewish Medical Center, New Hyde Park, NY 11042

  • Closed to Enrollment

    New York

    New York Medical College at Westchester Medical Center, Valhalla, NY 10595

  • Closed to Enrollment

    Ohio

    University of Cincinnati Medical Center, Cincinnati, OH 45267

  • Closed to Enrollment

    Ohio

    Children's Hospital Medical Center of Akron, Akron, OH 44308

  • Closed to Enrollment

    Ohio

    Northwest Ohio Cystic Fibrosis Center, Toledo, OH 43606

  • Closed to Enrollment

    Pennsylvania

    University of Pennsylvania, Philadelphia, PA 19104

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Texas

    University of Texas Southwestern, Dallas, TX 75390

  • Closed to Enrollment

    Vermont

    University of Vermont Medical Center, Burlington, VT 05401

  • Closed to Enrollment

    Virginia

    Inova Fairfax, Falls Church, VA 22042

  • Closed to Enrollment

    Washington

    Providence Medical Group, Cystic Fibrosis Clinic, Spokane, WA 99204

  • Closed to Enrollment

    Washington

    University of Washington Medical Center, Seattle, WA 98195

  • Closed to Enrollment

    Wisconsin

    University of Wisconsin, Madison, WI 53792

  • Closed to Enrollment

    Wisconsin

    Froedtert & Medical College of Wisconsin, Milwaukee, WI 53226

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    50 to 100%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Eligible participants will need to have had at least one pulmonary exacerbation requiring antibiotic treatment in the 12 months prior to enrollment. This study is enrolling both people with CF and people without CF that have bronchiectasis.  

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