Back to resultsAdult Asthmatics and Acid Reflux
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Esomeprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Acid Reflux, Nexium, Esomeprazole
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores
Secondary Outcome Measures
Safety as assessed by adverse event recording and clinical and laboratory measurements.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00628953
Brief Title
Adult Asthmatics and Acid Reflux
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Acid Reflux, Nexium, Esomeprazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40mg twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
40mg twice a day
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Safety as assessed by adverse event recording and clinical and laboratory measurements.
Time Frame
4 weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Fernstrom
Organizational Affiliation
Nexium Global Product Director, AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Adult Asthmatics and Acid Reflux
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