Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis
Status:
Completed
Trial end date:
2010-06-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Children's Hospital Srebrnjak
Collaborators:
Belupo Belupo d.d., Koprivnica, Croatia University Hospital Center Sisters of Charity, Zagreb, Croatia