MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
Public ClinicalTrials.gov record NCT01180634. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis 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. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.
Study identification
- NCT ID
- NCT01180634
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 330 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 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
- Nov 4, 2010 (Actual)
- Primary completion
- May 7, 2012 (Actual)
- Completion
- May 7, 2012 (Actual)
- Last update posted
- Dec 18, 2024
2010 – 2012
United States locations
- U.S. sites
- 95
- U.S. states
- 41
- U.S. cities
- 85
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mobile | Alabama | 36608 | — |
| Not listed | Anchorage | Alaska | 99508 | — |
| Not listed | Phoenix | Arizona | 85016 | — |
| Not listed | Tucson | Arizona | 85724 | — |
| Not listed | La Jolla | California | 92037 | — |
| Not listed | Long Beach | California | 90806 | — |
| 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 | San Francisco | California | 94115 | — |
| Not listed | San Francisco | California | 94143 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Denver | Colorado | 80206 | — |
| Not listed | Hartford | Connecticut | 06106 | — |
| Not listed | Wilmington | Delaware | 19803 | — |
| Not listed | Jacksonville | Florida | 32207 | — |
| Not listed | Miami | Florida | 33136 | — |
| Not listed | Orlando | Florida | 32801 | — |
| Not listed | St. Petersburg | Florida | 33701 | — |
| Not listed | Tampa | Florida | 33606 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Boise | Idaho | 83712 | — |
| Not listed | Chicago | Illinois | 60614 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Glenview | Illinois | 60025 | — |
| Not listed | Niles | Illinois | 60714 | — |
| Not listed | Indianapolis | Indiana | 46202 | — |
| Not listed | Wichita | Kansas | 67214 | — |
| Not listed | Lexington | Kentucky | 40536 | — |
| Not listed | Louisville | Kentucky | 40202 | — |
| Not listed | New Orleans | Louisiana | 70011 | — |
| Not listed | Portland | Maine | 04102 | — |
| Not listed | Boston | Massachusetts | 02114 | — |
| Not listed | Boston | Massachusetts | 02115 | — |
| Not listed | Worcester | Massachusetts | 01655 | — |
| Not listed | Ann Arbor | Michigan | 48109 | — |
| Not listed | Detroit | Michigan | 48201 | — |
| Not listed | Grand Rapids | Michigan | 49503 | — |
| Not listed | Minneapolis | Minnesota | 55455 | — |
| Not listed | Jackson | Mississippi | 39216 | — |
| Not listed | Columbia | Missouri | 65212 | — |
| Not listed | Kansas City | Missouri | 64108 | — |
| Not listed | St Louis | Missouri | 63104 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | Omaha | Nebraska | 68198 | — |
| Not listed | Las Vegas | Nevada | 89107 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Manchester | New Hampshire | 03104 | — |
| Not listed | Livingston | New Jersey | 07039 | — |
| Not listed | Long Branch | New Jersey | 07440 | — |
| Not listed | Morristown | New Jersey | 07962 | — |
| Not listed | Albuquerque | New Mexico | 87131 | — |
| Not listed | Albany | New York | 12208 | — |
| Not listed | New York | New York | 10003 | — |
| Not listed | New York | New York | 10011 | — |
| Not listed | New York | New York | 10032 | — |
| Not listed | Syracuse | New York | 13210 | — |
| Not listed | Valhalla | New York | 10595 | — |
| Not listed | Chapel Hill | North Carolina | 27599 | — |
| Not listed | Akron | Ohio | 44308 | — |
| Not listed | Cincinnati | Ohio | 45229 | — |
| Not listed | Columbus | Ohio | 43205 | — |
| Not listed | Dayton | Ohio | 45404 | — |
| Not listed | Toledo | Ohio | 43606 | — |
| Not listed | Oklahoma City | Oklahoma | 73104 | — |
| Not listed | Oklahoma City | Oklahoma | 73112 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Philadelphia | Pennsylvania | 19102 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Pittsburgh | Pennsylvania | 15224 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
| Not listed | Columbia | South Carolina | 29203 | — |
| Not listed | Sioux Falls | South Dakota | 57117 | — |
| Not listed | Memphis | Tennessee | 38105 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | Austin | Texas | 78723 | — |
| Not listed | Dallas | Texas | 75390 | — |
| Not listed | Fort Worth | Texas | 76104 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | San Antonio | Texas | 78212 | — |
| Not listed | Tyler | Texas | 75708 | — |
| Not listed | Salt Lake City | Utah | 84132 | — |
| Not listed | Colchester | Vermont | 05446 | — |
| Not listed | Charlottesville | Virginia | 22908 | — |
| Not listed | Norfolk | Virginia | 23507 | — |
| Not listed | Portsmouth | Virginia | 23708 | — |
| Not listed | Richmond | Virginia | 23298 | — |
| Not listed | Seattle | Washington | 98105 | — |
| Not listed | Seattle | Washington | 98195 | — |
| Not listed | Morgantown | West Virginia | 26506 | — |
| Not listed | Milwaukee | Wisconsin | 53201 | — |
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 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01180634, 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 18, 2024 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01180634 live on ClinicalTrials.gov.