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Observational Closed to Enrollment

Phase 4 TOBI Podhaler observational study (Novartis CTBM100C2407)

This study is taking place at multiple care centers across the U.S. It will look at the effectiveness and long term safety of the TOBI Podhaler and other FDA-approved inhaled antipseudomonal drugs.

 This observational study will look at the effectiveness and long term safety of the TOBI Podhaler and other FDA-approved antipseudomonal drugs. Researchers will test the effectiveness of these drugs by measuring lung function and the amount of Pseudomonas aeruginosa in sputum. They will also track pulmonary exacerbations and other measures.This study is for people with cystic fibrosis who have a chronic Pseudomonas aeruginosa infection. This study may require lung function tests, sputum cultures and/or other measurements.

Eligibility

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 80%

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

Study Design

  • Study Type: ?more info

    Observational

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    60 months

  • Number of Study Visits:

    22

Additional Information

  • Phase: ?more info

    Phase Four/Post-Approval

  • Study Sponsor: ?more info

    Novartis

  • Study Drugs:

    N/A

Study Sites

  • Closed to Enrollment

    Alaska

    Providence Alaska Medical Center, Anchorage, AK 99508

  • Closed to Enrollment

    Arkansas

    Arkansas Children's Hospital, Little Rock, AR 72202

  • Closed to Enrollment

    California

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

  • Closed to Enrollment

    California

    Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, CA 90033

  • Closed to Enrollment

    California

    Valley Children’s Cystic Fibrosis Center in affiliation with Stanford School of Medicine, Madera, CA 93636

  • Closed to Enrollment

    California

    Kaiser Permanente Southern California CF Center, Los Angles, CA 90027

  • Closed to Enrollment

    Connecticut

    Yale University School of Medicine, New Haven, CT 06520

  • Closed to Enrollment

    Connecticut

    The Marie and Raymond Beauregard Adult CF Center at Hartford Hospital, Hartford, CT 06102

  • Closed to Enrollment

    Florida

    Central Florida Pulmonary Group, Orlando, FL 32803

  • Closed to Enrollment

    Florida

    Tampa General Hospital, Tampa, FL 33606

  • Closed to Enrollment

    Florida

    University of Florida, Gainesville, FL 32610

  • Closed to Enrollment

    Georgia

    Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30329

  • Closed to Enrollment

    Georgia

    Augusta University, Augusta, GA 30912

  • Closed to Enrollment

    Idaho

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

  • Closed to Enrollment

    Illinois

    Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611

  • Closed to Enrollment

    Indiana

    Riley Hospital for Children, Indianapolis, IN 46202

  • Closed to Enrollment

    Iowa

    University of Iowa, Iowa City, IA 52242

  • Closed to Enrollment

    Kansas

    University of Kansas Medical Center, Kansas City, KS 66160

  • Closed to Enrollment

    Louisiana

    Tulane University, Metairie, LA 70006

  • Closed to Enrollment

    Massachusetts

    Boston Children's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Michigan

    Corewell Health Helen DeVos, Grand Rapids , MI 49503

  • Closed to Enrollment

    Michigan

    Children's Hospital of Michigan, Detroit, MI 48201

  • Closed to Enrollment

    Missouri

    Children's Mercy Kansas City, Kansas City, MO 64108

  • Closed to Enrollment

    Montana

    Billings Clinic , Billings, MT 59101

  • Closed to Enrollment

    Nebraska

    University of Nebraska Medical Center, Omaha, NE 68114

  • Closed to Enrollment

    New Jersey

    Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ 08901

  • Closed to Enrollment

    New York

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

  • Closed to Enrollment

    New York

    Cohen Children's Medical Center of New York, New Hyde Park, NY 11042

  • Closed to Enrollment

    New York

    Children's Hospital of New York, New York, NY 10032

  • Closed to Enrollment

    North Carolina

    Atrium Health Wake Forest Baptist, Winston-Salem, NC 27157

  • Closed to Enrollment

    Ohio

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

  • Closed to Enrollment

    Oklahoma

    Oklahoma Cystic Fibrosis Center, OKC, OK 73104

  • Closed to Enrollment

    Pennsylvania

    Drexel University College of Medicine, Philadelphia, PA 19102

  • Closed to Enrollment

    Pennsylvania

    Hershey Medical Center Pennsylvania State University, Hershey, PA 17033

  • Closed to Enrollment

    Pennsylvania

    University of Pennsylvania, Philadelphia, PA 19104

  • Closed to Enrollment

    South Dakota

    Sanford USD Medical Center, Sioux Falls, SD 57117

  • Closed to Enrollment

    Tennessee

    Vanderbilt Children's Hospital, Nashville, TN 37232

  • Closed to Enrollment

    Texas

    University of Texas Southwestern / Children’s Health, Dallas, TX 75207

  • Closed to Enrollment

    Texas

    University of Texas Health Center at Tyler, Tyler, TX 75708

  • Closed to Enrollment

    Texas

    Dell Children's Medical Center of Central Texas, Austin, TX 78723

  • Closed to Enrollment

    Utah

    Adult Cystic Fibrosis Center at the University of Utah, Salt Lake City, UT 84112

  • Closed to Enrollment

    Vermont

    University of Vermont Medical Center, Burlington, VT 05401

  • Closed to Enrollment

    Vermont

    Vermont Children's Hospital, Burlington, VT 05401

  • Closed to Enrollment

    Virginia

    Virginia Commonwealth University, Richmond, VA 23219

  • Closed to Enrollment

    Washington

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

  • Closed to Enrollment

    Wisconsin

    Froedtert & Medical College of Wisconsin, Milwaukee, WI 53226

Eligibility

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 80%

  • Pseudomonas Status:

    Positive Respiratory Cultures Required

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

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