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

NCT00745849 | Completed Results

• 1 other identifier: Efficacy Esomeprazole NAR
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vasomotor Rhinitis

Keywords

non-allergic rhinitis, laryngopharyngeal reflux

Outcome Measures

Primary Outcomes (1)

• 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

  Last two weeks of each treatment arm

Study Arms (2)

1

EXPERIMENTAL

esomeprazole 40mg po bid

Drug: esomeprazole

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

esomeprazole DRUG

40mg by mouth twice daily

Also known as: Nexium

1

placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Clinical Trials Office, Aston Building, UT Southwestern

Dallas, Texas, 75390-9016, United States

Location

MeSH Terms

Conditions

Rhinitis, Vasomotor; Common Cold; Laryngopharyngeal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Six patients did not complete the study and may have affected the outcome. Optimal duration for treatment of laryngopharyngeal reflux is unclear.

Results Point of Contact

• Title: Ganesh Shanmugam, MD
• Organization: University of Texas Southwestern

ganesh01@yahoo.com

9797036112

Study Officials

• David A Khan, MD

  Department of Allergy and Immunology, UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 3, 2008
• Study Start: June 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-06

Locations

US (1)