Adult Asthmatics and Acid Reflux
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...
Brief Summary
Official Title: “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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: April 2004
Intervention(s) in this Clinical Trial
- Drug: Esomeprazole
- 40mg twice a day
- Drug: Placebo
- 40mg twice a day
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores
- Time Frame: 4 weekly
- Time Frame: 4 weekly
Secondary Measures
- Safety as assessed by adverse event recording and clinical and laboratory measurements.
- Time Frame: 4 weekly
- Time Frame: 4 weekly
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00628953
Study ID Number: SD-NEE-0003
ClinicalTrials.gov Identifier: NCT00628953
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00628953
