Investigators: Dr. Weiss, Dr. Lahiri, Dr. Whittaker	Coordinators: (together Amy & Angela, seperately Lorriane Bourassa)

1. Measurement of Bacterial Shedding in Cystic Fibrosis Clinics:  While most current information suggests that the amount of bacterial spread is very low, this study is being performed at eight Cystic Fibrosis Centers in the United States to help us to clearly understand the risks of bacterial infection in the doctor’s office. 
2. A Randomized, Open-label, Phase 3 Trial to Assess the Safety and Efficacy of Tobramycin Powder for Inhalation (TPI) Compared to TOBI® Over Three Cycles (28 Days On Treatment/28 Days Off Treatment For 6 Months) in Cystic Fibrosis (CF) Subjects 6 Years of Age and Older:  This study is being performed to determine if TPI is equally safe and effective in the treatment of Pseudomonas aeruginosa colonized Cystic Fibrosis patients.
3. EPIC (Early Pseudomonas Infection Control) Clinical Trial:  There are two parts to this study which will study different treatment regimens for children (ages 1 to 12 years) who are newly infected with Pseudomonas aeruginosa
   
   

   a.	EPIC Observational Study: will follow children ages 1-12 years for 5 years who have NOT been infected with Pseudomonas aeruginosa over the past two years and are not receiving anti-pseudomonal therapy.
   b.	Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas aeruginosa Airway Infection in Young Patients with Cystic Fibrosis: children will be randomized to receive TOBI with or without ciprofloxacin following a new Pseudomonas infection for 18 months.

    
4. Diabetes Therapy to Improve BMI and Pulmonary Function in Cystic Fibrosis Subjects with Abnormal Glucose ToleranceInhaled Insulin:  This study will examine whether two common treatments for diabetes, insulin injections and oral pills, will promote weight gain and increased muscle mass in Cystic Fibrosis (CF) patients with impaired glucose tolerance.
5. Inhaled Insulin for Cystic Fibrosis-Related Diabetes:  Inhaled insulin has not yet been evaluated in patients with Cystic Fibrosis-related diabetes.  One of the issues to be determined is whether the chronic lung disease in Cystic Fibrosis will allow enough insulin to be absorbed if inhaled.  This project will assess the blood levels of insulin following a single inhalation and compare those to the blood levels obtained after injection of a comparable amount of insulin.  The specific goal of the project is to determine whether enough inhaled insulin gets absorbed to be effective in controlling the diabetes.
6. The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients:  A Pilot  Study - This study will examine the effect of Pulmozyme, compared to placebo, in the prevention of recurrent sinus disease in patients ages 5 and over who have just undergone sinus surgery
   

For more information call either Dr. Tom Lahiri at 847-8600 or Dr. Laurie Whittaker at 847-1158.