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

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ClinicalTrials.gov Identifier: NCT01270347
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.

Tracking Information
First Submitted Date  ICMJE January 3, 2011
First Posted Date  ICMJE January 5, 2011
Last Update Posted Date January 19, 2018
Study Start Date  ICMJE January 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2012)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
  • Safety [ Time Frame: 168 days ]
    Assessment of adverse events and safety from Baseline through Final Visit
  • Efficacy [ Time Frame: 28 Days ]
    Percent change in percent predicted FEV1 from Baseline to Day 28
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients
Official Title  ICMJE 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
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™).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • Experimental: Aeroquin
    Aeroquin, Inhaled Levofloxacin (MP-376)
    Intervention: Drug: MP-376 (Levofloxacin Solution for Inhalation)
  • Active Comparator: TIS
    Tobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals]
    Intervention: Drug: TIS (Tobramycin Inhalation Solution)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2011)
267
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Ireland,   Israel,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01270347
Other Study ID Numbers  ICMJE Mpex-209
2010-019634-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Horizon Pharma USA, Inc.
Study Sponsor  ICMJE Horizon Pharma USA, Inc.
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Patrick Flume, M.D. Medical University of South Carolina
PRS Account Horizon Pharma USA, Inc.
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP