Adult Asthmatics and Acid Reflux
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Esomeprazole (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores
Secondary outcome: Safety as assessed by adverse event recording and clinical and laboratory measurements.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 2002
Ending date: June 2004
Last updated: March 4, 2008
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