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
|Condition or disease||Intervention/treatment||Phase|
|Rhinitis Nasal Obstruction GERD||Drug: lansoprazole Drug: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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.
the lansoprazole placebo will be taken orally.
- 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 .
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
|Contact: John J Manoukian, MD, FRCSC, FACS||( 514 ) 412-4400 ext firstname.lastname@example.org|
|Contact: Abdullah A Alarfaj, MD.||514 email@example.com|