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Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients (TIS)
This study has been completed.
Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01270347
First received: January 3, 2011
Last updated: July 11, 2013
Last verified: July 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Cystic Fibrosis | Drug: MP-376 (Levofloxacin Solution for Inhalation) Drug: TIS (Tobramycin Inhalation Solution) | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
Drug Information available for:
Tobramycin
Tobramycin sulfate
Ofloxacin
Levofloxacin
Ofloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Safety [ Time Frame: 168 and 336 days ]
Assessment of adverse events and safety from Baseline through Final Visit
Extension portion of Study: Descriptive statistics for all patients receiving at least one dose of MP-376 in the extension phase of the study will be summarized for the safety, microbiology, and disease-related endpoints. No formal hypothesis tests are planned.
- Efficacy [ Time Frame: 28 Days ]Percent change in percent predicted FEV1 from Baseline to Day 28
Secondary Outcome Measures:
- Changes in respiratory and other domains of CFQ-R from Baseline to Day 28 [ Time Frame: 28 days ]
- Evaluate changes in FEV1 and FVC from Baseline to Day 28 [ Time Frame: 28 days ]
- Changes in bacterial load and susceptability patterns of isolated organisms from Baseline to Day 28 [ Time Frame: 28 days ]
| Enrollment: | 267 |
| Study Start Date: | January 2011 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aeroquin
Aeroquin, Inhaled Levofloxacin (MP-376)
|
Drug: MP-376 (Levofloxacin Solution for Inhalation)
MP-376 (Aeroquin, Levofloxacin solution for Inhalation) 240 mg administered BID for 28-days treatment followed by 28 days off treatment
Other Name: (Aeroquin, Levofloxacin solution for Inhalation)
|
|
Active Comparator: TIS
Tobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals]
|
Drug: TIS (Tobramycin Inhalation Solution)
Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment
Other Name: TOBI
|
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 </= 85% of predicted value at 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01270347
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01270347
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Locations
| United States, Alabama | |
| Mobile, Alabama, United States, 36608 | |
| United States, Alaska | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Phoenix, Arizona, United States, 85016 | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| La Jolla, California, United States, 92037 | |
| Long Beach, California, United States, 90806 | |
| Childrens Hospital | |
| Los Angeles, California, United States, 90027 | |
| Los Angeles, California, United States, 90033 | |
| Oakland, California, United States, 94611 | |
| Orange, California, United States, 92868 | |
| Palo Alto, California, United States, 94304 | |
| Sacramento, California, United States, 95817 | |
| San Diego, California, United States, 92103 | |
| San Diego, California, United States, 92123 | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| Aurora, Colorado, United States, 80045 | |
| Denver, Colorado, United States, 80206 | |
| United States, Connecticut | |
| Hartford, Connecticut, United States, 06106 | |
| New Haven, Connecticut, United States, 65020 | |
| United States, Delaware | |
| Wilmington, Delaware, United States, 19803 | |
| United States, Florida | |
| Gainesville, Florida, United States, 32610 | |
| Jacksonville, Florida, United States, 32207 | |
| Miami, Florida, United States, 33136 | |
| Orlando, Florida, United States, 32801 | |
| St. Petersburg, Florida, United States, 33701 | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Idaho | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60614 | |
| Chicago, Illinois, United States, 60637 | |
| Glenview, Illinois, United States, 60025 | |
| Niles, Illinois, United States, 60714 | |
| Peoria, Illinois, United States, 61637 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 43202 | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maine | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| Boston, Massachusetts, United States, 02115 | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Detroit, Michigan, United States, 48201 | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Columbia, Missouri, United States, 65212 | |
| Kansas City, Missouri, United States, 64108 | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68105 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89107 | |
| United States, New Hampshire | |
| Lebanon, New Hampshire, United States, 03756 | |
| Manchester, New Hampshire, United States, 03104 | |
| United States, New Jersey | |
| Livingston, New Jersey, United States, 07039 | |
| Morristown, New Jersey, United States, 07962 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Albany Medical College #2 | |
| Albany, New York, United States, 12208 | |
| Albany, New York, United States, 12208 | |
| New Hyde Park, New York, United States, 11042 | |
| New York, New York, United States, 10003 | |
| New York, New York, United States, 10032 | |
| Syracuse, New York, United States, 13210 | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Akron, Ohio, United States, 44308 | |
| Cincinnati, Ohio, United States, 45229 | |
| Columbus, Ohio, United States, 43205 | |
| Dayton, Ohio, United States, 45404 | |
| Toledo, Ohio, United States, 43606 | |
| United States, Oklahoma | |
| Oklahoma CF Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Pennsylvania | |
| Hershey, Pennsylvania, United States, 17033 | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Columbia, South Carolina, United States, 29203 | |
| United States, South Dakota | |
| Sioux Falls, South Dakota, United States, 57117 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 38105 | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Austin, Texas, United States, 78723 | |
| Dallas, Texas, United States, 75390 | |
| Fort Worth, Texas, United States, 76104 | |
| Houston, Texas, United States, 77030 | |
| San Antonio, Texas, United States, 78212 | |
| Tyler, Texas, United States, 75708 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Vermont | |
| Colchester, Vermont, United States, 05446 | |
| United States, Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Norfolk, Virginia, United States, 23507 | |
| Portsmouth, Virginia, United States, 23708 | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Seattle, Washington, United States, 98105 | |
| United States, West Virginia | |
| Morgantown, West Virginia, United States, 26506 | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States, 53201 | |
| Milwaukee, Wisconsin, United States, 53266 | |
| France | |
| Hôpital Pellegrin Enfants - CHU Bordeaux | |
| Bordeaux, France, 33076 | |
| CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve | |
| Montpellier, France, 34295 | |
| Hôpital Cochin | |
| Paris, France, 75014 | |
| Hôpital Necker-Enfants Malades | |
| Paris, France, 75743 | |
| Hôpital Haut-Lévêque CHU de Bordeaux | |
| Pessac, France, 33604 | |
| CRCM adulte Hôpital Larrey-CHU de Toulouse | |
| Toulouse, France, 31059 | |
| Germany | |
| 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 | |
| Ireland | |
| Cork University Hospital | |
| Cork, Ireland | |
| Beaumont Hospital | |
| Dublin, Ireland | |
| National Children's Hospital Tallaght | |
| Dublin, Ireland | |
| St. Vincent's University Hospital | |
| Dublin, Ireland | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Hadassah Medical Center Mount Scopus | |
| Jerusalem, Israel, 91240 | |
| Schneider Childrens Medical Center of Israel | |
| Petah Tikva, Israel, 49202 | |
| Safra Childrens Hospital, Sheba Medical Center | |
| Ramat Gan, Israel, 52621 | |
| United Kingdom | |
| Belfast City Hospital | |
| Belfast, United Kingdom, BT9 7AB | |
| Birmingham Heartlands Hospital | |
| Birmingham, United Kingdom, B95SS | |
| Castle Hill Hospital | |
| Cottingham, East Yorkshire, United Kingdom, HU16 5JQ | |
| St James's University Hospital | |
| Leeds, United Kingdom, LS97TF | |
| King's College Hospital | |
| London, United Kingdom, SE59RS | |
| University Hospital Llandough, Penarth | |
| Penarth, United Kingdom, CF64 2XX | |
Sponsors and Collaborators
Forest Laboratories
Investigators
| Principal Investigator: | Patrick Flume, M.D. | Medical University of South Carolina |
More Information
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01270347 History of Changes |
| Other Study ID Numbers: |
Mpex-209 |
| Study First Received: | January 3, 2011 |
| Last Updated: | July 11, 2013 |
Additional relevant MeSH terms:
|
Fibrosis Cystic Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pharmaceutical Solutions Levofloxacin Ofloxacin |
Tobramycin Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Anti-Bacterial Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on July 14, 2017