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MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis

Sponsor
Horizon Pharma USA, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01180634
Collaborator
Forest Laboratories (Industry)
330
Enrollment
112
Locations
2
Arms
22
Duration (Months)
2.9
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. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.

Condition or Disease Intervention/Treatment Phase
  • Drug: MP-376 (Levofloxacin solution for Inhalation)
  • Drug: Placebo
 Phase 3

Detailed Description

This trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as MP-376 given for 28 days by the aerosol route to CF patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Inhaled MP-376 (Aeroquin)

Drug: MP-376 (Levofloxacin solution for Inhalation)
240 mg of MP-376 administered BID for 28 days
Placebo Comparator: 2

Placebo

Drug: Placebo
same volume and frequency as study drug

Outcome Measures

Primary Outcome Measures

  1. Time to an exacerbation [56 days]

Secondary Outcome Measures

  1. Time to administration of other anti-pseudomonal antimicrobials [56 days]

  2. Evaluate changes in FEV1, FEF 25-75 and FVC from baseline to end of treatment [28 days]

  3. Changes in bacterial load and susceptibility patterns of isolated organisms from baseline to end of treatment [28 days]

  4. Changes in respiratory domain of CFQ-R from baseline to end of treatment baseline to end of treatment [28 days]

  5. Evaluate the safety of MP-376 administered over 28 days, compared to placebo [56 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 at screening and 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 antimicrobials 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 intolerance with aerosol medication

  • Evidence of respiratory infections within 14 days prior to dosing

  • CrCl < 20ml/min or < 20ml/min/1.73 m2 at Screening

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 La Jolla California United States 92037
6 Long Beach California United States 90806
7 Childrens Hospital Los Angeles California United States 90027
8 Los Angeles California United States 90033
9 Oakland California United States 94611
10 Orange California United States 92868
11 Palo Alto California United States 94304
12 Sacramento California United States 95817
13 San Diego California United States 92103
14 San Francisco California United States 94115
15 San Francisco California United States 94143
16 Aurora Colorado United States 80045
17 Denver Colorado United States 80206
18 Hartford Connecticut United States 06106
19 Wilmington Delaware United States 19803
20 Jacksonville Florida United States 32207
21 Miami Florida United States 33136
22 Orlando Florida United States 32801
23 Saint Petersburg Florida United States 33701
24 Tampa Florida United States 33606
25 Atlanta Georgia United States 30322
26 Boise Idaho United States 83712
27 Chicago Illinois United States 60614
28 Chicago Illinois United States 60637
29 Glenview Illinois United States 60025
30 Niles Illinois United States 60714
31 Indianapolis Indiana United States 46202
32 Wichita Kansas United States 67214
33 Lexington Kentucky United States 40536
34 Louisville Kentucky United States 40202
35 New Orleans Louisiana United States 70011
36 Portland Maine United States 04102
37 Boston Massachusetts United States 02114
38 Boston Massachusetts United States 02115
39 Worcester Massachusetts United States 01655
40 Ann Arbor Michigan United States 48109
41 Detroit Michigan United States 48201
42 Grand Rapids Michigan United States 49503
43 Minneapolis Minnesota United States 55455
44 Jackson Mississippi United States 39216
45 Columbia Missouri United States 65212
46 Kansas City Missouri United States 64108
47 Saint Louis Missouri United States 63104
48 Saint Louis Missouri United States 63110
49 Omaha Nebraska United States 68198
50 Las Vegas Nevada United States 89107
51 Lebanon New Hampshire United States 03756
52 Manchester New Hampshire United States 03104
53 Livingston New Jersey United States 07039
54 Long Branch New Jersey United States 07440
55 Morristown New Jersey United States 07962
56 Albuquerque New Mexico United States 87131
57 Albany New York United States 12208
58 New York New York United States 10003
59 New York New York United States 10011
60 New York New York United States 10032
61 Syracuse New York United States 13210
62 Valhalla New York United States 10595
63 Chapel Hill North Carolina United States 27599
64 Akron Ohio United States 44308
65 Cincinnati Ohio United States 45229
66 Columbus Ohio United States 43205
67 Dayton Ohio United States 45404
68 Toledo Ohio United States 43606
69 Oklahoma City Oklahoma United States 73104
70 Oklahoma City Oklahoma United States 73112
71 Hershey Pennsylvania United States 17033
72 Philadelphia Pennsylvania United States 19102
73 Philadelphia Pennsylvania United States 19104
74 Pittsburgh Pennsylvania United States 15224
75 Charleston South Carolina United States 29425
76 Columbia South Carolina United States 29203
77 Sioux Falls South Dakota United States 57117
78 Memphis Tennessee United States 38105
79 Nashville Tennessee United States 37232
80 Austin Texas United States 78723
81 Dallas Texas United States 75390
82 Fort Worth Texas United States 76104
83 Houston Texas United States 77030
84 San Antonio Texas United States 78212
85 Tyler Texas United States 75708
86 Salt Lake City Utah United States 84132
87 Colchester Vermont United States 05446
88 Charlottesville Virginia United States 22908
89 Norfolk Virginia United States 23507
90 Portsmouth Virginia United States 23708
91 Richmond Virginia United States 23298
92 Seattle Washington United States 98105
93 Seattle Washington United States 98195
94 Morgantown West Virginia United States 26506
95 Milwaukee Wisconsin United States 53201
96 Westmead Chilren's Hospital Westmead New South Wales Australia
97 Westmead Hospital Westmead New South Wales Australia
98 Mater Miscericordiae Hospital Brisbane Queensland Australia
99 Brisbane Queensland Australia
100 Royal Adelaide Hospital Adelaide South Australia Australia
101 Royal Children's Hospital Melbourne Victoria Australia
102 The Alfred Hospital Melbourne Victoria Australia
103 Monash Medical Center Melbourne Australia
104 John Hunter Hospital New South Wales Australia
105 Hamilton Ontario Canada L8N3Z5
106 Kingston Ontario Canada K7L5G2
107 Ottawa Ontario Canada K1H8L6
108 Rambam Medical Center Haifa Israel 31096
109 Hadassah Medical Center Mount Scopus Jerusalem Israel 91240
110 Schneider Childrens Medical Center of Israel Petah Tikva Israel 49202
111 Sheba Medical Center Ramat-Gan Israel 52620
112 Auckland Hospital Auckland New Zealand

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:
NCT01180634
Other Study ID Numbers:
  • Mpex-207
  • 2010-019515-38
First Posted:
Aug 12, 2010
Last Update Posted:
Jan 19, 2018
Last Verified:
Jan 1, 2018
Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Levofloxacin
Ofloxacin

Study Results

No Results Posted as of Jan 19, 2018