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

Study Overview
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Brief Summary
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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.

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

Conditions
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Laryngopharyngeal Reflux, Chronic Rhinosinusitis (Diagnosis)

Intervention / Treatment
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* Drug: Omeprazole 20mg
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: laryngopharyngeal reﬂux chronic rhinosinusitis Exclusion Criteria: allergic rhinitis asthma cystic fibrosis nasal polyposis severe systemic diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double blind, placebo controlled trial
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adults, omeprazole, placebo, treatment