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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00745849
First received: August 29, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

No publications provided

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:
Rhinitis
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014