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

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086070
• Other study ID #: CHS-ENT01
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2010
• Est. completion date: June 30, 2010

Study information

• Verified date: December 2020
• Source: Children's Hospital Srebrnjak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2010
• Est. primary completion date: April 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• laryngopharyngeal re?ux
• chronic rhinosinusitis

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Gastroesophageal Reflux
• Laryngopharyngeal Reflux
• Sinusitis

Intervention

Drug:
• Omeprazole 20mg
omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks
• Placebo oral capsule
Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Srebrnjak	Belupo, University Hospital Center Sisters of Charity, Zagreb, Croatia

References & Publications (1)

Anzic SA, Turkalj M, Župan 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. Cli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in signs and symptoms of laryngopharyngeal re?ux	Re?ux symptom index (RSI) score	8 weeks
Primary	Reduction in signs and symptoms of laryngopharyngeal re?ux	Re?ux finding score (RFS)	8 weeks
Secondary	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
Secondary	Association of the severity of signs and symptoms of laryngopharyngeal re?ux with the ones of chronic rhinosinusitis		Baseline and after 8 weeks of treatment.