GERD Clinical Trial
Official title:
The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate. A Randomized Controlled Trial
Gastroesophageal(GERD) reflux disease is a very common problem among pediatric population and has be proved to contribute in numerous otolaryngological manifestations. Trails of empirical treatment of antireflux medications is often used as a diagnostic test. However, the investigators believe GERD can cause rhinitis and nasal obstruction. Nasonex is considered as first line treatment for nasal obstruction. Hence, the proposed study aims to define the relationship between GERD and rhinitis using randomize control trial where one group of patients will receive nasonex and placebo, while the other group will receive nasonex and antireflux medications.
The proposed study is a randomized controlled trial in which children with nasal obstruction
will be randomized to receive either antireflux medication lansoprazole (prevacid) and
mometasone furonate (nasonex) or only nasonex and placebo. The diagnosis of nasal
obstruction will be made by history and physical examination.
The study will take place at Montreal children's hospital. After the patients or parents of
the patients agree for their children to take part in the study and sign a consent/assent
form, baseline information will be collected and the patients will asked to fill out three
questionnaires for GERD symptoms and nasal symptom. After that eligible patients will
undergo sinus x-ray, nasal endoscopy and allergy skin test (these test are routine performed
for all patients with symptoms of nasal obstruction). Then the patients will further be
sub-divided into two groups based on the allergic skin prick test (SPT); allergy positive
and allergy negative group. In each group patients will randomly allocated to one of the two
study arms; group A will receive lansoprazole (prevacid) and mometasone furonate (nasonex)
and the other group will receive nasonex and placebo. The lansoprazole/placebo will be
discontinued after 3 months and the patients will undergo nasal endoscopy and will be asked
to fill out the three questionnaires again to assess the improvement. The patients will be
follow for another 3 months, the patients will again undergo nasal endoscopy and will asked
to fill out the three questionnaires to assess the improvement and sustainability.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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