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

This study has been completed.
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
First received: August 29, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis

Condition Intervention
Vasomotor Rhinitis
Drug: esomeprazole
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-Blind, Placebo Controlled Trial

Resource links provided by NLM:

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Nasal Symptom scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • non-nasal symptom scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • reflux scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • quality of life scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: June 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
esomeprazole 40mg po bid
Drug: esomeprazole
40mg by mouth twice daily
Other Name: Nexium
Placebo Comparator: 2 Drug: placebo


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00745849

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
Principal Investigator: David A Khan, MD Department of Allergy and Immunology, UT Southwestern
  More Information

Responsible Party: David A. Khan, MD, UT Southwestern
ClinicalTrials.gov Identifier: NCT00745849     History of Changes
Other Study ID Numbers: Efficacy Esomeprazole NAR 
Study First Received: August 29, 2008
Last Updated: August 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
non-allergic rhinitis, laryngopharyngeal reflux

Additional relevant MeSH terms:
Common Cold
Rhinitis, Vasomotor
Nose Diseases
Otorhinolaryngologic Diseases
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016