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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MP-376 (Levofloxacin Solution for Inhalation)
TIS (Tobramycin Inhalation Solution)
Sponsored by
Horizon Pharma USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Childrens Hospital
  • Albany Medical College #2
  • Oklahoma CF Center
  • Hôpital Pellegrin Enfants - CHU Bordeaux
  • CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve
  • Hôpital Cochin
  • Hôpital Necker-Enfants Malades
  • Hôpital Haut-Lévêque CHU de Bordeaux
  • CRCM adulte Hôpital Larrey-CHU de Toulouse
  • Charité Campus Virchow-Klinikum
  • Universitätskinderklinik Dresden Mukoviszidose-Ambulanz
  • Universitätsklinikum Essen
  • Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik
  • Universitätsklinikum Frankfurt
  • Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin
  • Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro
  • Universitätsklinikum Kiel
  • Ludwig-Maximilians Universität Klinikum Innenstadt
  • Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz
  • Universitätsklinik für Kinder- und Jugendmedizin
  • Cork University Hospital
  • Beaumont Hospital
  • National Children's Hospital Tallaght
  • St. Vincent's University Hospital
  • Rambam Medical Center
  • Hadassah Medical Center Mount Scopus
  • Schneider Childrens Medical Center of Israel
  • Safra Childrens Hospital, Sheba Medical Center
  • Belfast City Hospital
  • Birmingham Heartlands Hospital
  • Castle Hill Hospital
  • St James's University Hospital
  • King's College Hospital
  • University Hospital Llandough, Penarth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aeroquin

TIS

Arm Description

Aeroquin, Inhaled Levofloxacin (MP-376)

Tobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals]

Outcomes

Primary Outcome Measures

Safety
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
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
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

Full Information

First Posted
January 3, 2011
Last Updated
January 17, 2018
Sponsor
Horizon Pharma USA, Inc.
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01270347
Brief Title
Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients
Acronym
TIS
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 Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Horizon Pharma USA, Inc.
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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™).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aeroquin
Arm Type
Experimental
Arm Description
Aeroquin, Inhaled Levofloxacin (MP-376)
Arm Title
TIS
Arm Type
Active Comparator
Arm Description
Tobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals]
Intervention Type
Drug
Intervention Name(s)
MP-376 (Levofloxacin Solution for Inhalation)
Other Intervention Name(s)
(Aeroquin, Levofloxacin solution for Inhalation)
Intervention Description
MP-376 (Aeroquin, Levofloxacin solution for Inhalation) 240 mg administered BID for 28-days treatment followed by 28 days off treatment
Intervention Type
Drug
Intervention Name(s)
TIS (Tobramycin Inhalation Solution)
Other Intervention Name(s)
TOBI
Intervention Description
Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
168 and 336 days
Title
Efficacy
Description
Percent change in percent predicted FEV1 from Baseline to Day 28
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Changes in respiratory and other domains of CFQ-R from Baseline to Day 28
Time Frame
28 days
Title
Evaluate changes in FEV1 and FVC from Baseline to Day 28
Time Frame
28 days
Title
Changes in bacterial load and susceptability patterns of isolated organisms from Baseline to Day 28
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Flume, M.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Childrens Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
65020
Country
United States
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
43202
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89107
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03104
Country
United States
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Albany Medical College #2
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Oklahoma CF Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53266
Country
United States
Facility Name
Hôpital Pellegrin Enfants - CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hôpital Haut-Lévêque CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CRCM adulte Hôpital Larrey-CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
Country
Germany
Facility Name
Universitätskinderklinik Dresden Mukoviszidose-Ambulanz
City
Dresden
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik
City
Frankfurt
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin
City
Gieben
Country
Germany
Facility Name
Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum Kiel
City
Kiel
Country
Germany
Facility Name
Ludwig-Maximilians Universität Klinikum Innenstadt
City
Munchen
Country
Germany
Facility Name
Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz
City
Munich
Country
Germany
Facility Name
Universitätsklinik für Kinder- und Jugendmedizin
City
Tubingen
Country
Germany
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Facility Name
National Children's Hospital Tallaght
City
Dublin
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center Mount Scopus
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Schneider Childrens Medical Center of Israel
City
Petah Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Safra Childrens Hospital, Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B95SS
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
ZIP/Postal Code
LS97TF
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE59RS
Country
United Kingdom
Facility Name
University Hospital Llandough, Penarth
City
Penarth
ZIP/Postal Code
CF64 2XX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26935334
Citation
Elborn JS, Flume PA, Cohen F, Loutit J, VanDevanter DR. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros. 2016 Sep;15(5):634-40. doi: 10.1016/j.jcf.2016.01.005. Epub 2016 Feb 28.
Results Reference
derived

Learn more about this trial

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

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