Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis

Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis - a Randomized, Double Blind, Placebo Controlled Trial

The hypothesis of this study is that a gastroesophageal reflux recommended treatment with proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis. Primary objective was to determine whether 8 weeks of treatment with omeprazole 20 mg ones daily (OD) significantly reduces the signs and symptoms of laryngopharyngeal reflux when compared to placebo in patients with laryngopharyngeal reflux with comorbid chronic rhinosinusitis. Secondary objectives were to determine whether 8 weeks of treatment with omeprazole 20 mg OD significantly reduces the signs and symptoms of comorbid chronic rhinosinusitis in patients with laryngopharyngeal reflux when compared to matching placebo; and to investigate the association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis in the same group of patients. The research was carried out as a double blind randomized placebo controlled trial. Patients were randomized into two groups in an approximate 1:1 ratio using a concealed random sequence. After randomization and initial assessment treatment was initialized. Patients on active treatment were given omeprazole 20 mg once daily half an hour before breakfast for 8 weeks, while those in the placebo group were given matching placebo tablets using the same regimen for 8 weeks as the group on the active treatment. Patients were reassessed at the end of treatment for signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis (Diagnosis); Laryngopharyngeal Reflux
• Intervention / Treatment: Drug: Omeprazole 20mg; Drug: Placebo oral capsule

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• laryngopharyngeal reflux
• chronic rhinosinusitis

Exclusion Criteria:

• allergic rhinitis
• asthma
• cystic fibrosis
• nasal polyposis
• severe systemic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; omeprazole 20 mg capsule once daily for 8 weeks	Drug: Omeprazole 20mg; omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks
Placebo Comparator: Placebo arm; matching placebo capsules ones daily for 8 weeks	Drug: Placebo oral capsule; Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in signs and symptoms of laryngopharyngeal reflux	Reflux symptom index (RSI) score	8 weeks
Reduction in signs and symptoms of laryngopharyngeal reflux	Reflux finding score (RFS)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of signs and symptoms of comorbid chronic rhinosinusitis	Nasal obstruction, anterior/posterior nasal drip, headache, sneezing, cough, smell and taste disorder with frequency and intensity of the symptoms was graded from 0 (no problem) to 3 (severe problem). Nasal endoscopy with endoscopy scores were based on the assessment of nasal mucosa edema, secretions and presence of polyps and were graded from 0 (no problem) to 3 (severe problem).	8 weeks
Association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis		Baseline and after 8 weeks of treatment.

Collaborators and Investigators

• Sponsor: Children's Hospital Srebrnjak
• Collaborators: Belupo; University Hospital Center Sisters of Charity, Zagreb, Croatia
• Investigators: Principal Investigator: Srđan A Anzić, MD, PhD, Children's Hospital Srebrnjak

Publications and helpful links

General Publications

• Anzic SA, Turkalj M, Zupan A, Labor M, Plavec D, Baudoin T. Eight weeks of omeprazole 20 mg significantly reduces both laryngopharyngeal reflux and comorbid chronic rhinosinusitis signs and symptoms: Randomised, double-blind, placebo-controlled trial. Clin Otolaryngol. 2018 Apr;43(2):496-501. doi: 10.1111/coa.13005. Epub 2017 Oct 23.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): April 30, 2010
• Study Completion (Actual): June 30, 2010

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: treatment; placebo; adults; omeprazole
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gastrointestinal Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Paranasal Sinus Diseases; Nose Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Sinusitis; Laryngopharyngeal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: CHS-ENT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Anonymised individual participant data can be obtained for other researchers on a written request to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No