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NCT01180634 · ClinicalTrials.gov registry record · Phase 3

MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis

A Phase 3 study of Cystic Fibrosis, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
330
Enrollment target
20
Study locations

NCT01180634 is a Phase 3 study of Cystic Fibrosis that has completed, run by Amgen. The registered enrollment target is 330 participants, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (86% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT01180634, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
330 participants
Enrollment target
20
Study locations

Study 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. 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.

Conditions Studied

Cystic Fibrosis

Interventions

  • DRUG Placebo
  • DRUG Aeroquin

Study Locations (20)

California

  • - La Jolla
  • - Long Beach
  • Childrens Hospital - Los Angeles
  • - Los Angeles
  • - Oakland
  • - Orange
  • - Palo Alto
  • - Sacramento
  • - San Diego
  • - San Francisco
  • - San Francisco

Arizona

  • - Phoenix
  • - Tucson

Colorado

  • - Aurora
  • - Denver

Alabama

  • - Mobile

Alaska

  • - Anchorage

Connecticut

  • - Hartford

Delaware

  • - Wilmington

Florida

  • - Jacksonville

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2010-11-04
Est. Completion 2012-05-07
Phase Phase 3

Sponsor

Amgen

558 total trials

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What the Registry Record Tells You About NCT01180634

The ClinicalTrials.gov registry entry for NCT01180634 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (86% higher). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01180634 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT01180634 about?

NCT01180634 is a clinical study titled "MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis". 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...

What is the current status of trial NCT01180634?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2010-11-04. Estimated completion is 2012-05-07.

What conditions does trial NCT01180634 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT01180634?

The interventions under investigation include: Placebo (DRUG), Aeroquin (DRUG).

Who is sponsoring clinical trial NCT01180634?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01180634 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.