Clinical trial NCT03086070: Omeprazole 20 mg in Patients With Laryngopharyngeal reﬂux and Comorbid Chronic Rhinosinusitis
Official title: Omeprazole 20 mg in Patients With Laryngopharyngeal reﬂux and Comorbid Chronic Rhinosinusitis - a Randomized, Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laryngopharyngeal Reflux
Chronic Rhinosinusitis (Diagnosis)
Keywords: omeprazole
placebo
treatment
adults
Lead sponsor: Children's Hospital Srebrnjak
Sponsor class: OTHER
Collaborators: name: University Hospital Center Sisters of Charity, Zagreb, Croatia
name: Belupo
First posted: 2017-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double blind, placebo controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* laryngopharyngeal reﬂux
* chronic rhinosinusitis

Exclusion Criteria:

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

Primary outcomes:
measure: Reduction in signs and symptoms of laryngopharyngeal reﬂux
timeFrame: 8 weeks
measure: Reduction in signs and symptoms of laryngopharyngeal reﬂux
timeFrame: 8 weeks
Secondary outcomes:
measure: Reduction of signs and symptoms of comorbid chronic rhinosinusitis
timeFrame: 8 weeks
measure: Association of the severity of signs and symptoms of laryngopharyngeal reﬂux with the ones of chronic rhinosinusitis
timeFrame: Baseline and after 8 weeks of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Srebrnjak
name: Srđan A Anzić, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.