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The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate (Pale Turbinate)

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ClinicalTrials.gov Identifier: NCT02278081
Recruitment Status : Unknown
Verified October 2014 by John Manoukian, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Not yet recruiting
First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
John Manoukian, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease Intervention/treatment Phase
Rhinitis Nasal Obstruction GERD Drug: lansoprazole Drug: placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate. A Randomized Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: treatment group
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.
Drug: lansoprazole
the lansoprazole will be taken orally.

Placebo Comparator: placebo group
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.
Drug: placebo
the lansoprazole placebo will be taken orally.




Primary Outcome Measures :
  1. improvement of the nasal signs and symptoms. [ Time Frame: three months ]
    after three months of treatment the patient symptoms will be evaluated using subjective questionnaires and nasal endoscopic exam .



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278081


Contacts
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Contact: John J Manoukian, MD, FRCSC, FACS ( 514 ) 412-4400 ext 25302 john.manoukian@mcgill.ca
Contact: Abdullah A Alarfaj, MD. 514 582-3229 abdullah.alarfaj@mail.mcgill.ca

Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications:

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Responsible Party: John Manoukian, Associate Professor, Faculty of Medicine, McGill University, Department of Otolaryngology-Head and Neck Surgery, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02278081     History of Changes
Other Study ID Numbers: 4225
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by John Manoukian, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Rhinitis (nasal obstruction) and GERD
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Rhinitis
Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action