Adult asthma program, allergic rhinitis program and Phase 1 pediatric asthma study.

Adult asthma program

In a global program of a combination product, INC Research managed a Phase 2 and 5 Phase 3 adult asthma studies. These studies were conducted at 339 sites across 12 countries in North America, Latin America and Europe. A total of 4,500 subjects were screened and 2,300 subjects were randomized over a 17 month period. Due to our expertise in respiratory diseases and our ability to manage large global studies; provide full service capabilities; and to maintain oversight of multiple studies in one program, the sponsor was able to submit their NDA to the FDA 3 months earlier than originally planned.

Allergic rhinitis program

INC Research was responsible for the complete development program of a new anti-histamine compound in allergic rhinitis and urticaria. This program included 16 Phase 1 studies, 5 Phase 2 studies and 7 Phase 3 studies. The total program enrolled more than 4000 subjects and over 3000 of these subjects were enrolled in one of the allergic rhinitis (either SAR or PAR) studies. The goal of the program was to submit to at least one EU country in 1Q09. INC Research was able to not only complete the program in a timely manner, but provide the sponsor with the necessary quality data to support a submission to Germany in March 2009.

Phase 1 pediatric asthma study

While INC Research has been very successful in adult indications of adult asthma and COPD, we have also been successful in pediatric studies as highlighted in this Phase 1 pediatric study example. A total of 31 pediatric subjects aged 4-11 years (58% were 4-6 years of age) were enrolled in a Phase 1 study conducted at 3 sites. The enrollment was completed in half the scheduled time and even though enrollment was much quicker than anticipated, the INC Research team was able to manage the data in such a way that less than 2% of the data were queried.