Back to resultsEfficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial
Primary Purpose
Vasomotor Rhinitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
esomeprazole
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vasomotor Rhinitis focused on measuring non-allergic rhinitis, laryngopharyngeal reflux
Eligibility Criteria
Inclusion Criteria:
- age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English
Exclusion Criteria:
- pregnancy or breast-feeding, evidence of positive skin tests to a common aeroallergen, treatment with a proton pump inhibitor within the month prior to enrollment, treatment with any other anti-reflux therapy within the last month on a daily basis or within the last two weeks on an as needed basis, and other gastrointestinal disorders leading to reflux symptoms
Sites / Locations
- Clinical Trials Office, Aston Building, UT Southwestern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
esomeprazole 40mg po bid
Outcomes
Primary Outcome Measures
Total Nasal Symptom Scores
(1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm
Secondary Outcome Measures
Full Information
NCT ID
NCT00745849
First Posted
August 29, 2008
Last Updated
June 10, 2019
Sponsor
University of Texas Southwestern Medical Center
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00745849
Brief Title
Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial
Official Title
Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Rhinitis
Keywords
non-allergic rhinitis, laryngopharyngeal reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
esomeprazole 40mg po bid
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40mg by mouth twice daily
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Total Nasal Symptom Scores
Description
(1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm
Time Frame
Last two weeks of each treatment arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English
Exclusion Criteria:
pregnancy or breast-feeding, evidence of positive skin tests to a common aeroallergen, treatment with a proton pump inhibitor within the month prior to enrollment, treatment with any other anti-reflux therapy within the last month on a daily basis or within the last two weeks on an as needed basis, and other gastrointestinal disorders leading to reflux symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Khan, MD
Organizational Affiliation
Department of Allergy and Immunology, UT Southwestern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials Office, Aston Building, UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial
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