Do you have Cystic Fibrosis and chronic lung infections caused by pseudomonas aeruginosa (PA)?


16531

A Phase 3, Randomized Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with Cystic Fibrosis

Medicine

Brown Cynthia, D

UVa Health System, is conducting a research study for those age 7 and older with Cystic Fibrosis and chronic lung infections cause by pseudomonas aeruginosa(PA) The purpose of the study is to evaluate the safety and effectiveness of continuous alternating therapy with Aztreonam for Inhalation Solution (AZLI – Cayston) and Tobramycin Inhaled Solution (TIS) for the treatment of chronic lung infections caused by pseudomonas aeruginosa. The study involves taking a 28-day cycle of Tobramycin Inhaled Solution (TIS). If you remain stable, you will then be placed into one of the following groups: • (3) 28-day cycles of AZLI alternating with TIS OR • (3) 28-day cycles of TIS alternating with an inactive placebo. In addition this study involves questionnaires, use of daily symptom log pad, medical history, physical examinations, use of bronchodilator, spirometry, blood draws, urine and sputum sampling, pregnancy testing for females, proper cleaning of study drug equipment and possibility of chest x-ray. A total of 9 study visits and a follow up telephone call will be conducted over 8 months. All visits will last approximately 2 hours. Study-related exams, lab tests, procedures, study drug and equipment provided free of charge. Compensation for study completion is $450.00 (or $50 per completed visit). Mileage reimbursement may be available. Contact Information: Patricia Moss, RN BSN CCRP 434-243-2876/pcm2v@virginia.edu IRB HSR # 16531 Principal Investigator: Cynthia D. Brown, MD Department of Pulmonary and Critical Care Medicine


Adult
Child

Cystic Fibrosis

Pulmonary/Respiratory

Ill

Compensation for study completion is $450.00 (or $50 per completed visit).

Patricia Moss

pcm2v@virginia.edu

4342432876