Adult Asthmatics and Acid Reflux
- Registration Number
- NCT00628953
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1400
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 Esomeprazole -
- Primary Outcome Measures
Name Time Method Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores 4 weekly
- Secondary Outcome Measures
Name Time Method Safety as assessed by adverse event recording and clinical and laboratory measurements. 4 weekly