Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Nasaleze International Limited, for conducting a pivotal study for Nasafort: a nasally applied cellulose powder in seasonal allergic rhinitis (SAR) in adults with grass pollen allergy during 4 weeks of the pollen season. It will be a randomized, double-blind, placebo-controlled and multi-center medical device investigation conducted in Ukraine.
Allergic rhinitis is a very common chronic condition affecting 65 million people in the United States. Although the condition is minor medically, the symptoms are troublesome. A range of treatments and remedies are available on prescription and over the counter, but nasal steroid sprays are considered the most effective. There is however a need for greater palliative treatment of allergic rhinitis and better prevention.
Nasafort is sold in Europe as a Class 1 medical device for managing hay fever. It is applied in the nostrils via a patented puffer device. When the bottle is squeezed, a puff of fine cellulose powder (Hydroxypropyl methylcellulose (HPMC)) is released into the nose and reacts with moisture on the mucous membrane to form a gel layer. This layer acts as a barrier between the nose and allergy particle in the air, thus blocking them.
Previous studies have shown its efficacy in the absence of any clinically significant adverse effects. The purpose of this pivotal study is to obtain additional evidence of the efficacy and safety of Nasafort in adult patients with SAR aged 18 to 40 years old with SAR to grass pollen.
About Nasaleze Ltd.
Nasaleze International Limited is an Isle of Man based medical device company which has developed Nasafort (also known as Nasaleze and other trade names), a fast-acting nasal spray for the treatment of allergic rhinitis. It is currently available in Boots, under the name of Boots Allergy Barrier in the United Kingdom, other countries where the product is sold, United States, Russia, China, France, Germany, Sweden, Netherlands, India, Korea and 15 + other countries. Nasaleze is registered with FDA in the USA.
About Clinical Accelerator
Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe. The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnological and medical device industries.
Clinical Accelerator employs a cost-effective model of conducting clinical trials with a special focus on their accelerated implementation. The ultimate goal is to bring much needed pharmaceutical products and medical devices to the market faster.