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

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ClinicalTrials.gov Identifier: NCT00745849
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : September 3, 2008
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
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

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. Nasal Symptom scores [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. non-nasal symptom scores [ Time Frame: 8 weeks ]
  2. reflux scores [ Time Frame: 8 weeks ]
  3. quality of life scores [ Time Frame: 8 weeks ]


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

Responsible Party: David A. Khan, MD, UT Southwestern
ClinicalTrials.gov Identifier: NCT00745849     History of Changes
Other Study ID Numbers: Efficacy Esomeprazole NAR
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: September 3, 2008
Last Verified: August 2008

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

Additional relevant MeSH terms:
Rhinitis
Common Cold
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