Adult Asthmatics and Acid Reflux

A Randomized, Double-Blind, Parallel Group Multicenter Efficacy and Safety Phase IIB Pilot Study of Esomeprazole 40mg Bid Versus Placebo Bid in Adult Asthmatics Treated for 4 Months

The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.

Inclusion Criteria:

• Clinical diagnosis of asthma
• Forced Expiratory Volume and Peak Expiratory Flow as defined by the protocol
• Daily use of inhaled GCS and/or leukotriene pathway modifier for greater than 3 months.
• Severe heartburn 3 days/week during the run-in period.

Exclusion Criteria:

• Subjects with a history of 3 sinus infections treated with antibiotics in the year prior to Visit 1.
• Any other significant disease or pathology judged to be clinically significant by the investigator