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: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

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

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
    

Secondary Measures

• Safety as assessed by adverse event recording and clinical and laboratory measurements.
  • Time Frame: 4 weekly
    

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

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca  

Information obtained from ClinicalTrials.gov on September 05, 2008

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