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Anti-Inflammatory Closed to Enrollment

Phase 2 study of LAU-7b in adults with CF (APPLAUD) (Laurent LAU-14-01)

This study is taking place at multiple care centers across the U.S. It will look at the safety and effectiveness of the anti-inflammatory drug LAU-7b and will use a placebo control.

 This study is placebo controlled, meaning that some participants will receive the study drug and others will receive a placebo. Researchers will test the effectiveness of LAU-7b by measuring lung function. They will also test its safety by monitoring the frequency of adverse events. This study is for adults with cystic fibrosis.This study is not for people who have had a positive Burkholderia cepacia culture in the past 12 months or who are being treated for allergic bronchopulmonary aspergillosis (ABPA). This study may require lung function tests, sputum samples, blood draws and/or other measurements.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 100%

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

Other Primary Eligibility Criteria

Must have had history of pulmonary exacerbation, defined as at least one (1) pulmonary exacerbation in the year prior to Screening which resulted in documented IV or oral antibiotics

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    189 days

  • Number of Study Visits:

    6

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Laurent Pharma

  • Study Drugs:

    LAU-7b

Study Sites

  • Closed to Enrollment

    California

    Children's Hospital of Los Angeles, Los Angeles, CA 90027

  • Closed to Enrollment

    California

    University of California at Davis Medical Center, Sacramento, CA 95817

  • Closed to Enrollment

    California

    Long Beach Memorial Medical Center, Long Beach, CA 90806

  • Closed to Enrollment

    District of Columbia

    Children's National Medical Center, Washington, DC 20010

  • Closed to Enrollment

    Florida

    University of Florida, Gainesville, FL 32610

  • Closed to Enrollment

    Florida

    Pensacola Lung Group, Pensacola, FL 32503

  • Closed to Enrollment

    Florida

    Joe DiMaggio Children's Hospital, Hollywood, FL 33021

  • Closed to Enrollment

    Idaho

    Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702

  • Closed to Enrollment

    Indiana

    Riley Hospital for Children, Indianapolis, IN 46202

  • Closed to Enrollment

    Kansas

    University of Kansas Medical Center, Kansas City, KS 66160

  • Closed to Enrollment

    Maine

    MaineHealth Pediatric Specialty Care, Portland, ME 04102

  • Closed to Enrollment

    Michigan

    University of Michigan, Michigan Medicine, Ann Arbor, MI 48109

  • Closed to Enrollment

    Michigan

    Children's Hospital of Michigan, Detroit, MI 48201

  • Closed to Enrollment

    Minnesota

    The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455

  • Closed to Enrollment

    Missouri

    Washington University School of Medicine, St. Louis, MO 63110

  • Closed to Enrollment

    New Jersey

    Morristown Medical Center , Morristown, NJ 07960

  • Closed to Enrollment

    New Jersey

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

  • Closed to Enrollment

    New York

    Albany Medical College, Albany, NY 12208

  • Closed to Enrollment

    Ohio

    Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Closed to Enrollment

    Oklahoma

    Oklahoma Cystic Fibrosis Center, OKC, OK 73104

  • Closed to Enrollment

    Oregon

    Oregon Health & Science University, Portland, OR 97239

  • Closed to Enrollment

    Pennsylvania

    Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Utah

    Primary Children's Cystic Fibrosis Center, Salt Lake City, UT 84113

  • Closed to Enrollment

    Virginia

    Virginia Commonwealth University, Richmond, VA 23219

  • 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:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 100%

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

Other Primary Eligibility Criteria

Must have had history of pulmonary exacerbation, defined as at least one (1) pulmonary exacerbation in the year prior to Screening which resulted in documented IV or oral antibiotics

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