Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients - Full Text View

Sponsored by:	Mpex Pharmaceuticals
Information provided by:	Mpex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00677365

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: Placebo	Phase II

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Antibiotics Cystic Fibrosis

Drug Information available for: Levofloxacin Ofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients

Further study details as provided by Mpex Pharmaceuticals:

Primary Outcome Measures:

Change in P. aeruginosa density from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in respiratory and other domains of CFQ-R from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Time to administration of other anti-pseudomonal antimicrobials [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Evaluate changes in FEV1 and FVC from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Changes in bacterial load and susceptability patterns of isolated organisms from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Evaluate the safety and tolerability of three dosage regimens of MP-376 administered over 28 days, compared to placebo [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	June 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Inhaled MP-376	Drug: MP-376 (Levofloxacin solution for Inhalation) 3 dose regimens of MP-376 administered BID or QD for 28 days
2: Placebo Comparator Placebo	Drug: Placebo same dose and frequency as study drug

Detailed Description:

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

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria (selected):

> 16 years of age
Confirmed Diagnosis of Cystic Fibrosis
Positive sputum culture for P. aeruginosa within the past 18 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 30 days
Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

Use of any nebulized or systemic antibiotics within 30 days prior to baseline
History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
CrCl < 50mg/ml, AST, ALT or total bilirubin >/= 3 x ULN at Screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677365

Contacts

Contact: Elizabeth E Morgan	858-875-6671	lmorgan@mpexpharma.com
Contact: Jeff Loutit, M.D.	858-875-6665	jloutit@mpexpharma.com

Show 51 Study Locations

Sponsors and Collaborators

Mpex Pharmaceuticals

Investigators

Principal Investigator:

Douglas J Conrad, M.D.

UCSD

More Information

Responsible Party:	Mpex Pharmaceuticals, Inc. ( Elizabeth E. Morgan )
Study ID Numbers:	Mpex-204
Study First Received:	May 12, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00677365
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: Dutch Health Care Inspectorate

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Ofloxacin
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009