This study is a multi-center prospective, randomized, parallel group, open-label trial which will compare the effectiveness of LABA/ICS combination therapy with TIO/ICS combination therapy in delaying the time to exacerbation in Black patients with asthma.
Montefiore Medical Group sites in Bronx, NY: Grand Concourse and Bronx East
Elliot Israel, MD
Local Principal Investigator
Donald Raum, MD
Enrollment : June 30 – December 31, 2011
Last anticipated follow-up contact: December 31, 2012
A comparison will be made of the effectiveness of long-acting beta agonists (LABA)/inhaled corticosteroids (ICS) vs. tiotropium/ICS in delaying the time to exacerbation in Black patients with asthma. Patients with a clinical history consistent with asthma, who are receiving ICS/LABA combination therapy, or ICS monotherapy will be enrolled and randomized to either LABA/ICS or TIO/ICS. Subjects will be followed for 1 year from randomization and monitored for asthma exacerbations and changes in asthma symptoms.
Central team: Suzanne Palmer, PhD, SPalmer@olmmed.org
Local team: Claudia Lechuga, Study Coordinator, email@example.com
Luke Mark, Study Associate, firstname.lastname@example.org