Cystic Fibrosis with Chronic Pseudomonas Lung Infection (207)
Protocol Title Cystic Fibrosis - Cystic Fibrosis with Chronic Pseudomonas Lung Infection (207)
Summary MP-376 (also known as Aeroquin™), the investigational medication being tested in this research study, has an active ingredient of levofloxacin which is FDA-approved for those with lung infections.Participation in this trial will last 70 days.
Therapeutic Area Cystic Fibrosis
Age Range 12 years of age to no maximum age limit
Purpose A physician near you is testing the safety and effectiveness of MP-376 (inhaled Levofloxacin) with placebo (an inactive or "dummy" medication) in a quick 4-6 minute, easy-to-use aerosol delivery. This study medication is designed to provide high concentrations of levofloxacin at the site of infection in the lung with less potential for resistance and side effects compared to other routes of administration.

Qualified participants will receive study visits, study-realted laboratory work and study medication (MP-376) or placebo (dummy medication) at no cost and will be compensated for time and travel.
Who is Eligible? To participate you must:
  • 12 years of age or older
  • Weigh at least 66 pounds
  • Have a confirmed diagnosis of cystic fibrosis
  • Have previously used inhaled antibiotics
Who is Not Eligible? You are not eligible if you:
  • Have a hypersensitivity, allergy, or intolerance (e.g. joint or tendon disorders) to any of the following drugs: Ciprofloxacin®, Levaquin®, Noroxin®,Tequin®, Avelox®, Floxin®
  • Have a history of intolerance to bronchodilators or are unwilling to use one during the trial

A study physician will discuss other exclusions with you.

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