Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00745849
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dave Khan, University of Texas Southwestern Medical Center

Brief Summary:
The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis

Condition or disease Intervention/treatment Phase
Vasomotor Rhinitis Drug: esomeprazole Drug: placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial
Study Start Date : June 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arm Intervention/treatment
Experimental: 1
esomeprazole 40mg po bid
Drug: esomeprazole
40mg by mouth twice daily
Other Name: Nexium

Placebo Comparator: 2 Drug: placebo



Primary Outcome Measures :
  1. Total Nasal Symptom Scores [ Time Frame: Last two weeks of each treatment arm ]
    (1=none, 7=unbearably severe) difference in nasal symptom scores for the average of the last two weeks of each treatment arm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745849


Locations
Layout table for location information
United States, Texas
Clinical Trials Office, Aston Building, UT Southwestern
Dallas, Texas, United States, 75390-9016
Sponsors and Collaborators
University of Texas Southwestern Medical Center
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: David A Khan, MD Department of Allergy and Immunology, UT Southwestern
Layout table for additonal information
Responsible Party: Dave Khan, Professor of Internal Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00745849    
Other Study ID Numbers: Efficacy Esomeprazole NAR
First Posted: September 3, 2008    Key Record Dates
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019
Last Verified: June 2019
Keywords provided by Dave Khan, University of Texas Southwestern Medical Center:
non-allergic rhinitis, laryngopharyngeal reflux
Additional relevant MeSH terms:
Layout table for MeSH terms
Common Cold
Rhinitis
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action