Cystic Fibrosis with Chronic Pseudomonas Lung Infection (209)
Protocol Title Cystic Fibrosis - Cystic Fibrosis with Chronic Pseudomonas Lung Infection (209)
Summary MP-376 (also known as Aeroquin™), the medication being tested in this research study, has an active ingredient of levofloxacin which is FDA-approved and has a well established history of safety and efficacy in the treatment of lung infections. Participation in this trial will last 6 months.
Therapeutic Area Cystic Fibrosis
Age Range 12 years of age to no maximum age limit
Purpose A cystic fibrosis center in your local area is evaluating the safety and efficacy of MP-376 (inhaled levofloxacin) compared to inhaled tobramycin. This research study will evaluate MP-376 in a quick 4-6 minute, easy-to-use aerosol delivery. This 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 office visits, laboratory work and study medication (MP-376) or inhaled tobramycin 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 tobramycin
Who is Not Eligible? You are not eligible if you:
  • Have a hypersensitivity 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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