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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: Completed Phase 3 study of Cystic Fibrosis, sponsored by Amgen.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The start of the exacerbation was determined by the earliest date at which a participant concurrently met at least 4 of the 12 modified Fuchs symptoms/signs; discontinued from the study early; died; or received an antipseudomonal agent for an event that did not meet modified Fuchs criteria but was determined to be an exacerbation by the Blinded Exacerbation. Fuchs symptoms/signs; * Change in sputum * New or increased hemoptysis * Increased cough * Increased dyspnea * Malaise, fatigue or lethar
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2010-11-04 |
| Est. Completion | 2012-05-07 |
| Phase | Phase 3 |
What the finished NCT01180634 record still lists
NCT01180634 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (86% higher).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01180634's enrollment target sits among peer trials
330 19th of 169 higher than 151 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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