PARI's EFlow In Cystic Fibrosis Clinical Trial Of L-arginine

Main Category: Cystic Fibrosis
Also Included In: Clinical Trials / Drug Trials
Article Date: 30 Nov 2006 - 0:00 PDT

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PARI Aerosol Research Institute and The Hospital for Sick Children (SickKids) in Toronto are studying an inhaled L-arginine formulation delivered by PARI's eFlow to treat cystic fibrosis.

Dr. Felix Ratjen, chief of Respiratory Medicine and senior scientist in Physiology & Experimental Medicine at SickKids, is conducting the multi- centre, double-blind, randomized, placebo-controlled trial. The study evaluates the safety, tolerability, and durability of response to L-arginine therapy in cystic fibrosis (CF) patients.

In CF patients, nitric oxide formation and nitric oxide synthases, the enzymes responsible for the synthesis of nitric oxide, are decreased, which is believed to impair lung function. Lab studies have shown that adding L-arginine, the precursor of enzymatic nitric oxide formation, relaxes the trachea. The hope is that lung function in CF patients can be improved by increasing L-arginine concentrations.

"We are currently working on a variety of clinical trials aimed at helping cystic fibrosis sufferers live healthier and longer. The lab work conducted to date on L-arginine is very promising, and our hope is that this will lead to a new medication that will improve lives," said Dr. Martin Knoch, Managing Director of PARI. "SickKids is a wonderful research and clinical hospital, and we are pleased that we can work so closely together on this study."

Cystic fibrosis is an inherited chronic disease that affects the lungs and digestive systems of about 70,000 children and adults worldwide. Patients have a defective gene that causes the body to produce unusually thick, sticky mucus that clogs the lungs and leads to life-threatening lung infections. CF also obstructs the pancreas and stops natural enzymes from helping the body break down and absorb food. With the advancements in medical care over the last decades, the median age of survival has increased to 37. Additional information is available from the Cystic Fibrosis Foundation at http://www.cff.org.

About eFlow

eFlow, an electronic, portable nebulizer, enables extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane. Compared to other nebulizer systems, eFlow can produce aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, eFlow helps reduce the burden of taking daily inhaled treatments.

Additional information online at http://www.paripharma.com.

About SickKids

The Hospital for Sick Children (SickKids), affiliated with the University of Toronto, is Canada's most research-intensive hospital and the largest centre dedicated to improving children's health in the country. As innovators in child health, SickKids improves the health of children by integrating care, research and teaching. Our mission is to provide the best in complex and specialized care by creating scientific and clinical advancements, sharing our knowledge and expertise and championing the development of an accessible, comprehensive and sustainable child health system. For more information, please visit http://www.sickkids.ca. SickKids is committed to healthier children for a better world.

About PARI

PARI is a leading worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, and cystic fibrosis. PARI's primary focus is to provide patients with innovative products and services that help control disease. PARI also develops drug products for pulmonary and nasal administration as liquid aerosols and already has several clinical development programs ongoing, either partnered or on its own. PARI is headquartered in Starnberg, Germany, with a major presence in the United States and offices in Japan, United Kingdom, Russia, and China.

PARI Aerosol Research Institute
http://www.paripharma.com

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