NCT00503490

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 and reduce the emergence of resistant bacteria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

July 16, 2007

Last Update Submit

December 2, 2024

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of MP-376 administered twice a day for 14 days

    14 days

Secondary Outcomes (3)

  • Evaluate changes in the microbiology of CF sputum after 14 days of treatment with MP-376

    14 days

  • PK Profile of single-dose vs multi-dose of MP-376

    14 days

  • Evaluate changes in FEV1 and FVC over 14 days of Treatment

    14 days

Study Arms (2)

1

EXPERIMENTAL

Inhaled Levofloxacin

Drug: MP-376 (Levofloxacin solution for Inhalation)

2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

MP-376 (Levofloxacin solution for Inhalation)DRUG

40, 80, 120mg RDD

1
placeboDRUG

BID

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \> 16 years of age
  • Confirmed Diagnosis of Cystic Fibrosis
  • Positive sputum culture for P. aeruginosa within the past 6 months
  • Patients are able to elicit an FEV1 \>/= 40% of predicted value at screening
  • Clinically stable with no evidence of acute respiratory or lower respiratory infections within 28 days prior to dosing
  • Able to reproducibly perform spirometry measurements and be able to repeatedly produce sputum over several hours

You may not qualify if:

  • Use of any nebulized or systemic antibiotics within 4 weeks of starting study
  • History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
  • Uncontrolled diabetes or abnormal renal function
  • Tobacco use (smoking) in the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

La Jolla, California, 92037, United States

Location

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Palo Alto, California, 94303, United States

Location

Unknown Facility

Orlando, Florida, 32801, United States

Location

Unknown Facility

Kalamazoo, Michigan, 49007, United States

Location

Unknown Facility

Omaha, Nebraska, 68154, United States

Location

Unknown Facility

Albany, New York, 12208, United States

Location

Unknown Facility

New Hyde Park, New York, 11040, United States

Location

Unknown Facility

Columbus, Ohio, 43205, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73112, United States

Location

Unknown Facility

Charleston, South Carolina, 29203, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

San Antonio, Texas, 78212, United States

Location

Unknown Facility

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations

US(14)