The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate (Pale Turbinate)
Primary Purpose
Rhinitis, Nasal Obstruction, GERD
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
lansoprazole
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis focused on measuring Rhinitis (nasal obstruction) and GERD
Eligibility Criteria
Inclusion Criteria:
- 7 (seven) to 17 (seventeen) years of age.
- Nasal obstruction as main complaint.
Exclusion Criteria:
- Structural cause of nasal obstruction (deviated nasal septum, adenoid hypertrophy, nasal polyps, nasal tumors)
- Received antireflux medication during the last three months.
- Acute sinusitis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
treatment group
placebo group
Arm Description
The treatment group will receive 30 mg lansoprazole (prevacid) one capsule per day for three months and mometasone furonate (nasonex) one puff in each nostril per day for three months.
The placebo group will receive one capsule per day of prevacid placebo for three months and mometasone furonate (nasonex) one puff in each nostril per day for three months.
Outcomes
Primary Outcome Measures
improvement of the nasal signs and symptoms.
after three months of treatment the patient symptoms will be evaluated using subjective questionnaires and nasal endoscopic exam .
Secondary Outcome Measures
Full Information
NCT ID
NCT02278081
First Posted
October 21, 2014
Last Updated
October 27, 2014
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT02278081
Brief Title
The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate
Acronym
Pale Turbinate
Official Title
The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Nasal Obstruction, GERD
Keywords
Rhinitis (nasal obstruction) and GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
The treatment group will receive 30 mg lansoprazole (prevacid) one capsule per day for three months and mometasone furonate (nasonex) one puff in each nostril per day for three months.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive one capsule per day of prevacid placebo for three months and mometasone furonate (nasonex) one puff in each nostril per day for three months.
Intervention Type
Drug
Intervention Name(s)
lansoprazole
Intervention Description
the lansoprazole will be taken orally.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
the lansoprazole placebo will be taken orally.
Primary Outcome Measure Information:
Title
improvement of the nasal signs and symptoms.
Description
after three months of treatment the patient symptoms will be evaluated using subjective questionnaires and nasal endoscopic exam .
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
7 (seven) to 17 (seventeen) years of age.
Nasal obstruction as main complaint.
Exclusion Criteria:
Structural cause of nasal obstruction (deviated nasal septum, adenoid hypertrophy, nasal polyps, nasal tumors)
Received antireflux medication during the last three months.
Acute sinusitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John J Manoukian, MD, FRCSC, FACS
Phone
( 514 ) 412-4400
Ext
25302
Email
john.manoukian@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah A Alarfaj, MD.
Phone
514 582-3229
Email
abdullah.alarfaj@mail.mcgill.ca
12. IPD Sharing Statement
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The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate
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