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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270347
First Posted: January 5, 2011
Last Update Posted: July 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forest Laboratories
  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: 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

Resource links provided by NLM:


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

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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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270347


  Show 130 Study Locations
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
First Submitted: January 3, 2011
First Posted: January 5, 2011
Last Update Posted: July 12, 2013
Last Verified: July 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