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

NCT ID: NCT03086070

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-01

Study Completion Date

2010-06-30

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.

Detailed Description

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Conditions

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Laryngopharyngeal Reflux Chronic Rhinosinusitis (Diagnosis)

Keywords

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omeprazole placebo treatment adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double blind, placebo controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment arm

omeprazole 20 mg capsule once daily for 8 weeks

Group Type EXPERIMENTAL

Omeprazole 20mg

Intervention Type DRUG

omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks

Placebo arm

matching placebo capsules ones daily for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks

Interventions

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Omeprazole 20mg

omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks

Intervention Type DRUG

Placebo oral capsule

Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* laryngopharyngeal reflux
* chronic rhinosinusitis

Exclusion Criteria

* allergic rhinitis
* asthma
* cystic fibrosis
* nasal polyposis
* severe systemic diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Center Sisters of Charity, Zagreb, Croatia

UNKNOWN

Sponsor Role collaborator

Belupo

OTHER

Sponsor Role collaborator

Children's Hospital Srebrnjak

OTHER

Sponsor Role lead

Responsible Party

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Davor Plavec

Assoc.Prof., MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Srđan A Anzić, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Srebrnjak

References

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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.

Reference Type RESULT
PMID: 29024410 (View on PubMed)

Other Identifiers

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CHS-ENT01

Identifier Type: -

Identifier Source: org_study_id