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

This study has been completed.
Sponsor:
Collaborators:
University Hospital Center Sisters of Charity, Zagreb, Croatia
Belupo d.d., Koprivnica, Croatia
Information provided by (Responsible Party):
Davor Plavec, Children's Hospital Srebrnjak
ClinicalTrials.gov Identifier:
NCT03086070
First received: March 6, 2017
Last updated: March 15, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Laryngopharyngeal Reflux Chronic Rhinosinusitis (Diagnosis) Drug: Omeprazole 20mg Drug: Placebo oral capsule Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, double blind, placebo controlled trial
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis - a Randomized, Double Blind, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Davor Plavec, Children's Hospital Srebrnjak:

Primary Outcome Measures:
  • Reduction in signs and symptoms of laryngopharyngeal reflux [ Time Frame: 8 weeks ]
    Reflux symptom index (RSI) score

  • Reduction in signs and symptoms of laryngopharyngeal reflux [ Time Frame: 8 weeks ]
    Reflux finding score (RFS)


Secondary Outcome Measures:
  • 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).


  • 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. ]

Enrollment: 60
Actual Study Start Date: January 1, 2010
Study Completion Date: June 30, 2010
Primary Completion Date: April 30, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
omeprazole 20 mg capsule once daily for 8 weeks
Drug: Omeprazole 20mg
omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks
Placebo Comparator: Placebo arm
matching placebo capsules ones daily for 8 weeks
Drug: Placebo oral capsule
Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • laryngopharyngeal reflux
  • chronic rhinosinusitis

Exclusion Criteria:

  • allergic rhinitis
  • asthma
  • cystic fibrosis
  • nasal polyposis
  • severe systemic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03086070

Sponsors and Collaborators
Children's Hospital Srebrnjak
University Hospital Center Sisters of Charity, Zagreb, Croatia
Belupo d.d., Koprivnica, Croatia
Investigators
Principal Investigator: Srđan A Anzić, MD, PhD Children's Hospital Srebrnjak
  More Information

Responsible Party: Davor Plavec, Assoc.Prof., MD, PhD, Children's Hospital Srebrnjak
ClinicalTrials.gov Identifier: NCT03086070     History of Changes
Other Study ID Numbers: CHS-ENT01
Study First Received: March 6, 2017
Last Updated: March 15, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Anonymised individual participant data can be obtained for other researchers on a written request to the principal investigator.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Davor Plavec, Children's Hospital Srebrnjak:
omeprazole
placebo
treatment
adults

Additional relevant MeSH terms:
Gastroesophageal Reflux
Sinusitis
Laryngopharyngeal Reflux
Chronic Disease
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Laryngeal Diseases
Disease Attributes
Pathologic Processes
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017