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NCT Number: NCT03086070

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • laryngopharyngeal reflux
  • chronic rhinosinusitis

Exclusion criteria

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

Treatment and study plan

Omeprazole 20mg

Drug

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

Placebo oral capsule

Drug

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

Primary outcomes

  1. Reduction in signs and symptoms of laryngopharyngeal reflux

    Time frame: 8 weeks

    Reflux symptom index (RSI) score

  2. Reduction in signs and symptoms of laryngopharyngeal reflux

    Time frame: 8 weeks

    Reflux finding score (RFS)

Secondary outcomes

  1. Reduction of signs and symptoms of comorbid chronic rhinosinusitis

    Time frame: 8 weeks

    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).

  2. Association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis

    Time frame: Baseline and after 8 weeks of treatment.

Sponsors and collaborators

Lead sponsor

Children's Hospital Srebrnjak

Other

Collaborators

  • Belupo
  • University Hospital Center Sisters of Charity, Zagreb, Croatia

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 22, 2017
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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