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

Sponsor
Horizon Pharma USA, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01270347
Collaborator
Forest Laboratories (Industry)
267
Enrollment
130
Locations
2
Arms
29
Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MP-376 (Levofloxacin Solution for Inhalation)
  • Drug: TIS (Tobramycin Inhalation Solution)
 Phase 3

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™).

Study Design

Study Type:
Interventional
Actual Enrollment :
267 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • (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 Names:
  • TOBI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety [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.

    2. Efficacy [28 Days]

      Percent change in percent predicted FEV1 from Baseline to Day 28

    Secondary Outcome Measures

    1. Changes in respiratory and other domains of CFQ-R from Baseline to Day 28 [28 days]

    2. Evaluate changes in FEV1 and FVC from Baseline to Day 28 [28 days]

    3. Changes in bacterial load and susceptability patterns of isolated organisms from Baseline to Day 28 [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mobile Alabama United States 36608
    2 Anchorage Alaska United States 99508
    3 Phoenix Arizona United States 85016
    4 Tucson Arizona United States 85724
    5 Little Rock Arkansas United States 72202
    6 La Jolla California United States 92037
    7 Long Beach California United States 90806
    8 Childrens Hospital Los Angeles California United States 90027
    9 Los Angeles California United States 90033
    10 Oakland California United States 94611
    11 Orange California United States 92868
    12 Palo Alto California United States 94304
    13 Sacramento California United States 95817
    14 San Diego California United States 92103
    15 San Diego California United States 92123
    16 San Francisco California United States 94115
    17 Aurora Colorado United States 80045
    18 Denver Colorado United States 80206
    19 Hartford Connecticut United States 06106
    20 New Haven Connecticut United States 65020
    21 Wilmington Delaware United States 19803
    22 Gainesville Florida United States 32610
    23 Jacksonville Florida United States 32207
    24 Miami Florida United States 33136
    25 Orlando Florida United States 32801
    26 Saint Petersburg Florida United States 33701
    27 Tampa Florida United States 33606
    28 Atlanta Georgia United States 30322
    29 Boise Idaho United States 83712
    30 Chicago Illinois United States 60614
    31 Chicago Illinois United States 60637
    32 Glenview Illinois United States 60025
    33 Niles Illinois United States 60714
    34 Peoria Illinois United States 61637
    35 Indianapolis Indiana United States 43202
    36 Indianapolis Indiana United States 46202
    37 Wichita Kansas United States 67214
    38 Lexington Kentucky United States 40536
    39 Louisville Kentucky United States 40202
    40 Portland Maine United States 04102
    41 Baltimore Maryland United States 21287
    42 Boston Massachusetts United States 02114
    43 Boston Massachusetts United States 02115
    44 Worcester Massachusetts United States 01655
    45 Ann Arbor Michigan United States 48109
    46 Detroit Michigan United States 48201
    47 Grand Rapids Michigan United States 49503
    48 Minneapolis Minnesota United States 55455
    49 Jackson Mississippi United States 39216
    50 Columbia Missouri United States 65212
    51 Kansas City Missouri United States 64108
    52 Saint Louis Missouri United States 63110
    53 Omaha Nebraska United States 68105
    54 Las Vegas Nevada United States 89107
    55 Lebanon New Hampshire United States 03756
    56 Manchester New Hampshire United States 03104
    57 Livingston New Jersey United States 07039
    58 Morristown New Jersey United States 07962
    59 Albuquerque New Mexico United States 87131
    60 Albany Medical College #2 Albany New York United States 12208
    61 Albany New York United States 12208
    62 New Hyde Park New York United States 11042
    63 New York New York United States 10003
    64 New York New York United States 10032
    65 Syracuse New York United States 13210
    66 Valhalla New York United States 10595
    67 Durham North Carolina United States 27710
    68 Akron Ohio United States 44308
    69 Cincinnati Ohio United States 45229
    70 Columbus Ohio United States 43205
    71 Dayton Ohio United States 45404
    72 Toledo Ohio United States 43606
    73 Oklahoma CF Center Oklahoma City Oklahoma United States 73104
    74 Oklahoma City Oklahoma United States 73112
    75 Hershey Pennsylvania United States 17033
    76 Philadelphia Pennsylvania United States 19102
    77 Philadelphia Pennsylvania United States 19104
    78 Pittsburgh Pennsylvania United States 15224
    79 Charleston South Carolina United States 29425
    80 Columbia South Carolina United States 29203
    81 Sioux Falls South Dakota United States 57117
    82 Memphis Tennessee United States 38105
    83 Nashville Tennessee United States 37232
    84 Austin Texas United States 78723
    85 Dallas Texas United States 75390
    86 Fort Worth Texas United States 76104
    87 Houston Texas United States 77030
    88 San Antonio Texas United States 78212
    89 Tyler Texas United States 75708
    90 Salt Lake City Utah United States 84132
    91 Colchester Vermont United States 05446
    92 Charlottesville Virginia United States 22908
    93 Norfolk Virginia United States 23507
    94 Portsmouth Virginia United States 23708
    95 Richmond Virginia United States 23298
    96 Seattle Washington United States 98105
    97 Morgantown West Virginia United States 26506
    98 Milwaukee Wisconsin United States 53201
    99 Milwaukee Wisconsin United States 53266
    100 Hôpital Pellegrin Enfants - CHU Bordeaux Bordeaux France 33076
    101 CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve Montpellier France 34295
    102 Hôpital Cochin Paris France 75014
    103 Hôpital Necker-Enfants Malades Paris France 75743
    104 Hôpital Haut-Lévêque CHU de Bordeaux Pessac France 33604
    105 CRCM adulte Hôpital Larrey-CHU de Toulouse Toulouse France 31059
    106 Charité Campus Virchow-Klinikum Berlin Germany
    107 Universitätskinderklinik Dresden Mukoviszidose-Ambulanz Dresden Germany
    108 Universitätsklinikum Essen Essen Germany
    109 Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik Frankfurt Germany
    110 Universitätsklinikum Frankfurt Frankfurt Germany
    111 Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin Gieben Germany
    112 Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro Hamburg Germany
    113 Universitätsklinikum Kiel Kiel Germany
    114 Ludwig-Maximilians Universität Klinikum Innenstadt Munchen Germany
    115 Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz Munich Germany
    116 Universitätsklinik für Kinder- und Jugendmedizin Tubingen Germany
    117 Cork University Hospital Cork Ireland
    118 Beaumont Hospital Dublin Ireland
    119 National Children's Hospital Tallaght Dublin Ireland
    120 St. Vincent's University Hospital Dublin Ireland
    121 Rambam Medical Center Haifa Israel 31096
    122 Hadassah Medical Center Mount Scopus Jerusalem Israel 91240
    123 Schneider Childrens Medical Center of Israel Petah Tikva Israel 49202
    124 Safra Childrens Hospital, Sheba Medical Center Ramat Gan Israel 52621
    125 Belfast City Hospital Belfast United Kingdom BT9 7AB
    126 Birmingham Heartlands Hospital Birmingham United Kingdom B95SS
    127 Castle Hill Hospital Cottingham United Kingdom HU16 5JQ
    128 St James's University Hospital Leeds United Kingdom LS97TF
    129 King's College Hospital London United Kingdom SE59RS
    130 University Hospital Llandough, Penarth Penarth United Kingdom CF64 2XX

    Sponsors and Collaborators

    • Horizon Pharma USA, Inc.
    • Forest Laboratories

    Investigators

    • Principal Investigator: Patrick Flume, M.D., Medical University of South Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Horizon Pharma USA, Inc.
    ClinicalTrials.gov Identifier:
    NCT01270347
    Other Study ID Numbers:
    • Mpex-209
    • 2010-019634-26
    First Posted:
    Jan 5, 2011
    Last Update Posted:
    Jan 19, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis
    Levofloxacin
    Ofloxacin
    Tobramycin
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Jan 19, 2018