Asthma
Conditions
Keywords
Asthma, Acid Reflux, Nexium, Esomeprazole
Brief 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.
Interventions
DRUGEsomeprazole
40mg twice a day
DRUGPlacebo
40mg twice a day
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores | 4 weekly |
Secondary
| Measure | Time frame |
|---|---|
| Safety as assessed by adverse event recording and clinical and laboratory measurements. | 4 weekly |
Outcome results
None listed