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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
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis focused on measuring Rhinitis (nasal obstruction) and GERD

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 21, 2014
    Last Updated
    October 27, 2014
    Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
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    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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