Laryngopharyngeal Reflux, Chronic Rhinosinusitis (Diagnosis)
Conditions
Keywords
omeprazole, placebo, treatment, adults
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.
Interventions
DRUGOmeprazole 20mg
omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks
DRUGPlacebo oral capsule
Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks
Sponsors
University Hospital Center Sisters of Charity, Zagreb, Croatia
Belupo
Children's Hospital Srebrnjak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
randomized, double blind, placebo controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* laryngopharyngeal reflux * chronic rhinosinusitis
Exclusion criteria
* allergic rhinitis * asthma * cystic fibrosis * nasal polyposis * severe systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in signs and symptoms of laryngopharyngeal reflux | 8 weeks | Reflux symptom index (RSI) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of signs and symptoms of comorbid chronic rhinosinusitis | 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). |
| Association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis | Baseline and after 8 weeks of treatment. | — |
Outcome results
None listed