Overview

Adult Asthmatics and Acid Reflux

Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Esomeprazole
Criteria
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