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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00677365

Public ClinicalTrials.gov record NCT00677365. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 11:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00677365
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Amgen
Industry
Enrollment
151 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
16 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2008 (Type not available)
Primary completion
Jun 2009 (Actual)
Completion
Jun 2009 (Actual)
Last update posted
Dec 27, 2024

2008 – 2009

United States locations

U.S. sites
39
U.S. states
21
U.S. cities
37
Facility City State ZIP Site status
Not listed Mobile Alabama 36608 —
Not listed Phoenix Arizona 85016 —
Not listed Tucson Arizona 85724 —
Not listed Little Rock Arkansas 72202 —
Childrens Hospital Los Angeles California 90027 —
Not listed Los Angeles California 90033 —
Not listed Oakland California 94611 —
Not listed Orange California 92868 —
Not listed Palo Alto California 94304 —
Not listed Sacramento California 95817 —
Not listed San Diego California 92103 —
Not listed Miami Florida 33136 —
Not listed Orlando Florida 32801 —
Not listed Chicago Illinois 60025 —
Not listed Oak Lawn Illinois 60453 —
Not listed Park Ridge Illinois 60068 —
Not listed Iowa City Iowa 52242 —
Not listed Louisville Kentucky 40202 —
Not listed Boston Massachusetts 02115 —
Not listed Ann Arbor Michigan 48109 —
Not listed Kalamazoo Michigan 49007 —
Not listed Minneapolis Minnesota — —
Not listed Las Vegas Nevada 89107 —
Not listed Morristown New Jersey 07962 —
Not listed Albany New York 12208 —
Not listed Valhalla New York 10595 —
Not listed Cincinnati Ohio 45224 —
Not listed Columbus Ohio 43205 —
Not listed Dayton Ohio 45404 —
Oklahoma CF Center Oklahoma City Oklahoma 73104 —
Not listed Oklahoma City Oklahoma 73112 —
Not listed Philadelphia Pennsylvania 19102 —
Not listed Pittsburgh Pennsylvania 15213 —
Not listed Charleston South Carolina 29425 —
Not listed Columbia South Carolina 29203 —
Not listed Memphis Tennessee 38105 —
Not listed San Antonio Texas 78212 —
Not listed Tyler Texas 75708 —
Not listed Salt Lake City Utah 84132 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00677365, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 27, 2024 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00677365 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →