Wednesday, August 28, 2013 -- Syreon Corporation, a Contract Research Organization (CRO) with headquarters in Vancouver, BC, Canada, has been contracted by Novartis Pharmaceuticals Canada Inc., to conduct a non-interventional study to compare treatment convenience/satisfaction and participant-reported adherence/compliance in participants treated with TOBI POHDALER versus those treated with nebulized tobramycin treatment.
The study, named ESPRIT-CF, will be an observational, multicenter, parallel-group study involving participants with a diagnosis of cystic fibrosis. The study will enroll 200 participants at 10 investigative sites across Canada. The sites will enroll participants aged 6 years or greater who have been receiving inhaled tobramycin for a minimum period of 6 months and are then switched to TOBI-PODHALER or continued on nebulized tobramycin for at least another 6 months. Participants will be matched by age, gender, pulmonary function and presence of diabetes. The primary objective of the study will be to determine whether the convenience advantages of the TOBI PODHALER translated into better treatment adherence/compliance in real-world medial practice. Data will be obtained from a participant interview during the office visit, self-reported assessments and from a longitudinal review of the participant’s medical chart.
Cystic fibrosis is a multisystem disease affecting the digestive system, sweat glands, and the reproductive tract, but progressive lung disease continues to be the major cause of morbidity and mortality. The use of inhaled tobramycin has been an important advance in treatment for pseudomonas infections, reducing both morbidity and mortality, and is now routinely used in the management of this disease. However, the administration of tobramycin via nebulization is a complex and time-consuming process with a substantial participant and caregiver burden that reduce compliance and clinical effectiveness.
The new TOBI-PODHALER is an innovative combination of dry powder formulation and simple inhalation device that offers simplicity of administration, with superior participant preference, convenience and global satisfaction, with comparable clinical effectiveness.
“It is possible that the decreased participant treatment burden offered by this new device will lead to improved compliance and efficacy, although this remains to be determined.” said Dr. Paul Keown, MD, DSc., MBA & CEO of Syreon Corporation.
About Syreon Corporation - Syreon Corporation partners with global pharmaceuticals and biotech companies to provide a full suite of support services including study design, site selections, ethics submission, investigator training, participant recruitment, site monitoring, data management, statistical analysis, safety monitoring, medical reporting and economic analysis. Syreon has experience in many therapeutic areas including dermatology, rheumatology, neurology, psychiatry, ocular disease, respirology, cardiology, hepatology, gastroenterology, nephrology, metabolism and endocrinology, oncology, infectious disease, immunology, hematology, urology and women’s health. Syreon has experience in all phases of clinical trials from Phase 1 to Phase IV and has conducted studies globally at over 1000 investigative sites in 40 countries. For more information, visit the company website at www.syreon.com or contact Syreon at info@syreon.com
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