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| Name | Class |
|---|---|
| University Hospital Center Sisters of Charity, Zagreb, Croatia | UNKNOWN |
| Belupo | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | omeprazole 20 mg capsule once daily for 8 weeks |
|
| Placebo arm | Placebo Comparator | matching placebo capsules ones daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole 20mg | Drug | omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srđan A Anzić, MD, PhD | Children's Hospital Srebrnjak | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29024410 | Result | 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. |
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Anonymised individual participant data can be obtained for other researchers on a written request to the principal investigator.
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| ID | Term |
|---|---|
| D057045 | Laryngopharyngeal Reflux |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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randomized, double blind, placebo controlled trial
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| Placebo oral capsule | Drug | Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks |
|
| 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. |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |