DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: MP-376 (Levofloxacin Solution for Inhalation) (Drug); TIS (Tobramycin Inhalation Solution) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Patrick Flume, M.D., Principal Investigator, Affiliation: Medical University of South Carolina

Summary

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

Clinical Details

Official title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Safety

Efficacy

Secondary outcome:

Changes in respiratory and other domains of CFQ-R from Baseline to Day 28

Evaluate changes in FEV1 and FVC from Baseline to Day 28

Changes in bacterial load and susceptability patterns of isolated organisms from Baseline to Day 28

Detailed description: This study will assess the comparative safety of MP-376 (Aeroquin) and Tobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals] over three consecutive cycles of 28-days treatment followed by 28-days off in stable CF patients with chronic P. aeruginosa lung infection. Efficacy data for MP-376 and TIS at the end of the first 28-day treatment period will also be compared, as well as explored over multiple treatment cycles. Study patients participating in Mpex 209 will be given the option to participate in a six-month open label extension phase of the Mpex 209 protocol. The open label extension will allow enrolled patients to receive three additional courses of MP-376 (levofloxacin inhalation solution, Aeroquin™).

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria (selected):

- > 12 years of age

- Confirmed Diagnosis of Cystic Fibrosis

- Positive sputum culture for P. aeruginosa within the past 12 months

- Patients are able to elicit an FEV1 >/= 25% but screening

- Have received at least 3 courses of inhaled tobramycin over the preceding 12 months

- Clinically stable with no changes in health status within the last 28 days

- Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

- Use of any nebulized or systemic antibiotics within 28 days prior to baseline

- History of hypersensitivity to fluoroquinolones or inhaled or systemic

aminoglycosides including tobramycin or any excipients

- Evidence of acute upper within 10 days or lower respiratory infections within 28 days

prior to dosing

- CrCl < 20 at Screening

- History of lung transplantation

Extension Portion of the Study: Patients enrolled in Mpex 209 are permitted to participate in the open label extension as long as they complete Visit 7 (Day 168), provide informed consent for participation in the open label extension of in the study and are clinically stable, as assessed by the Investigator.

Locations and Contacts

Hôpital Pellegrin Enfants - CHU Bordeaux, Bordeaux 33076, France

CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve, Montpellier 34295, France

Hôpital Cochin, Paris 75014, France

Hôpital Necker-Enfants Malades, Paris 75743, France

Hôpital Haut-Lévêque CHU de Bordeaux, Pessac 33604, France

CRCM adulte Hôpital Larrey-CHU de Toulouse, Toulouse 31059, France

Charité Campus Virchow-Klinikum, Berlin, Germany

Universitätskinderklinik Dresden Mukoviszidose-Ambulanz, Dresden, Germany

Universitätsklinikum Essen, Essen, Germany

Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik, Frankfurt, Germany

Universitätsklinikum Frankfurt, Frankfurt, Germany

Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin, Gieben, Germany

Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro, Hamburg, Germany

Universitätsklinikum Kiel, Kiel, Germany

Ludwig-Maximilians Universität Klinikum Innenstadt, Munchen, Germany

Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz, Munich, Germany

Universitätsklinik für Kinder- und Jugendmedizin, Tubingen, Germany

Cork University Hospital, Cork, Ireland

Beaumont Hospital, Dublin, Ireland

National Children's Hospital Tallaght, Dublin, Ireland

St. Vincent's University Hospital, Dublin, Ireland

Rambam Medical Center, Haifa 31096, Israel

Hadassah Medical Center Mount Scopus, Jerusalem 91240, Israel

Schneider Childrens Medical Center of Israel, Petah Tikva 49202, Israel

Safra Childrens Hospital, Sheba Medical Center, Ramat Gan 52621, Israel

Belfast City Hospital, Belfast BT9 7AB, United Kingdom

Birmingham Heartlands Hospital, Birmingham B95SS, United Kingdom

Castle Hill Hospital, Cottingham, East Yorkshire HU16 5JQ, United Kingdom

St James's University Hospital, Leeds LS97TF, United Kingdom

King's College Hospital, London SE59RS, United Kingdom

University Hospital Llandough, Penarth, Penarth CF64 2XX, United Kingdom

Mobile, Alabama 36608, United States

Anchorage, Alaska 99508, United States

Phoenix, Arizona 85016, United States

Tucson, Arizona 85724, United States

Little Rock, Arkansas 72202, United States

La Jolla, California 92037, United States

Long Beach, California 90806, United States

Los Angeles, California 90033, United States

Childrens Hospital, Los Angeles, California 90027, United States

Oakland, California 94611, United States

Orange, California 92868, United States

Palo Alto, California 94304, United States

Sacramento, California 95817, United States

San Diego, California 92103, United States

San Diego, California 92123, United States

San Francisco, California 94115, United States

Aurora, Colorado 80045, United States

Denver, Colorado 80206, United States

Hartford, Connecticut 06106, United States

New Haven, Connecticut 65020, United States

Wilmington, Delaware 19803, United States

Gainesville, Florida 32610, United States

Jacksonville, Florida 32207, United States

Miami, Florida 33136, United States

Orlando, Florida 32801, United States

St. Petersburg, Florida 33701, United States

Tampa, Florida 33606, United States

Atlanta, Georgia 30322, United States

Boise, Idaho 83712, United States

Chicago, Illinois 60614, United States

Chicago, Illinois 60637, United States

Glenview, Illinois 60025, United States

Niles, Illinois 60714, United States

Peoria, Illinois 61637, United States

Indianapolis, Indiana 43202, United States

Indianapolis, Indiana 46202, United States

Wichita, Kansas 67214, United States

Lexington, Kentucky 40536, United States

Louisville, Kentucky 40202, United States

Portland, Maine 04102, United States

Baltimore, Maryland 21287, United States

Boston, Massachusetts 02114, United States

Boston, Massachusetts 02115, United States

Worcester, Massachusetts 01655, United States

Ann Arbor, Michigan 48109, United States

Detroit, Michigan 48201, United States

Grand Rapids, Michigan 49503, United States

Minneapolis, Minnesota 55455, United States

Jackson, Mississippi 39216, United States

Columbia, Missouri 65212, United States

Kansas City, Missouri 64108, United States

St. Louis, Missouri 63110, United States

Omaha, Nebraska 68105, United States

Las Vegas, Nevada 89107, United States

Lebanon, New Hampshire 03756, United States

Manchester, New Hampshire 03104, United States

Livingston, New Jersey 07039, United States

Morristown, New Jersey 07962, United States

Albuquerque, New Mexico 87131, United States

Albany, New York 12208, United States

Albany Medical College #2, Albany, New York 12208, United States

New Hyde Park, New York 11042, United States

New York, New York 10003, United States

New York, New York 10032, United States

Syracuse, New York 13210, United States

Valhalla, New York 10595, United States

Durham, North Carolina 27710, United States

Akron, Ohio 44308, United States

Cincinnati, Ohio 45229, United States

Columbus, Ohio 43205, United States

Dayton, Ohio 45404, United States

Toledo, Ohio 43606, United States

Oklahoma City, Oklahoma 73112, United States

Oklahoma CF Center, Oklahoma City, Oklahoma 73104, United States

Hershey, Pennsylvania 17033, United States

Philadelphia, Pennsylvania 19102, United States

Philadelphia, Pennsylvania 19104, United States

Pittsburgh, Pennsylvania 15224, United States

Charleston, South Carolina 29425, United States

Columbia, South Carolina 29203, United States

Sioux Falls, South Dakota 57117, United States

Memphis, Tennessee 38105, United States

Nashville, Tennessee 37232, United States

Austin, Texas 78723, United States

Dallas, Texas 75390, United States

Fort Worth, Texas 76104, United States

Houston, Texas 77030, United States

San Antonio, Texas 78212, United States

Tyler, Texas 75708, United States

Salt Lake City, Utah 84132, United States

Colchester, Vermont 05446, United States

Charlottesville, Virginia 22908, United States

Norfolk, Virginia 23507, United States

Portsmouth, Virginia 23708, United States

Richmond, Virginia 23298, United States

Seattle, Washington 98105, United States

Morgantown, West Virginia 26506, United States

Milwaukee, Wisconsin 53201, United States

Milwaukee, Wisconsin 53266, United States

Additional Information

Starting date: January 2011
Last updated: July 11, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017