Status:
COMPLETED
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
Lead Sponsor:
Amgen
Collaborating Sponsors:
Forest Laboratories
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 partic...
Detailed Description
This trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as MP-376 given for 28 days by the aerosol route to CF patients. Study wit...
Eligibility Criteria
Inclusion
- Inclusion Criteria (selected):
- \>/= 12 years of age
- Confirmed Diagnosis of Cystic Fibrosis
- Positive sputum culture for P. aeruginosa at screening and within the past 12 months
- Patients are able to elicit an FEV1 \>/= 25% but \</= 85% of predicted value at screening
- Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
- Clinically stable with no changes in health status within the last 28 days
- Able to reproducibly produce sputum and perform spirometry
- Exclusion Criteria (selected):
- Use of any nebulized or systemic antibiotics within 28 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- Evidence of respiratory infections within 14 days prior to dosing
- CrCl \< 20ml/min or \< 20ml/min/1.73 m2 at Screening
Exclusion
Key Trial Info
Start Date :
November 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2012
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT01180634
Start Date
November 4 2010
End Date
May 7 2012
Last Update
December 18 2024
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Mobile, Alabama, United States, 36608
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Anchorage, Alaska, United States, 99508
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Tucson, Arizona, United States, 85724