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

NCT03086070 | Completed Phase 4

• 1 other identifier: CHS-ENT01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Laryngopharyngeal Reflux; Chronic Rhinosinusitis (Diagnosis)

Keywords

omeprazole; placebo; treatment; adults

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Reduction of signs and symptoms of comorbid chronic rhinosinusitis

  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.

Study Arms (2)

Treatment arm

EXPERIMENTAL

omeprazole 20 mg capsule once daily for 8 weeks

Drug: Omeprazole 20mg

Placebo arm

PLACEBO COMPARATOR

matching placebo capsules ones daily for 8 weeks

Drug: Placebo oral capsule

Interventions

Omeprazole 20mg DRUG

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

Treatment arm

Placebo oral capsule DRUG

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

Placebo arm

Eligibility Criteria

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

You may qualify if:

• laryngopharyngeal reflux
• chronic rhinosinusitis

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Srebrnjak: lead
• University Hospital Center Sisters of Charity, Zagreb, Croatia: collaborator
• Belupo: collaborator

Related Publications (1)

• 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.

  PMID: 29024410 RESULT

MeSH Terms

Conditions

Laryngopharyngeal Reflux; Disease

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Srđan A Anzić, MD, PhD

  Children's Hospital Srebrnjak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof., MD, PhD

Model Details: randomized, double blind, placebo controlled trial

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 22, 2017
• Study Start: January 1, 2010
• Primary Completion: April 30, 2010
• Study Completion: June 30, 2010
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share