The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate
NCT ID: NCT02278081
Last Updated: 2014-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
98 participants
INTERVENTIONAL
2015-01-31
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lansoprazole to Treat Children With Asthma
NCT00442013
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
NCT00215787
A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy.
NCT00237068
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
NCT03015610
A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
NCT00220818
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
lansoprazole
the lansoprazole will be taken orally.
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.
placebo
the lansoprazole placebo will be taken orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
lansoprazole
the lansoprazole will be taken orally.
placebo
the lansoprazole placebo will be taken orally.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Nasal obstruction as main complaint.
Exclusion Criteria
* Received antireflux medication during the last three months.
* Acute sinusitis
7 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
John Manoukian
Associate Professor, Faculty of Medicine, McGill University, Department of Otolaryngology-Head and Neck Surgery
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Vandenplas Y, Rudolph CD, Di Lorenzo C, Hassall E, Liptak G, Mazur L, Sondheimer J, Staiano A, Thomson M, Veereman-Wauters G, Wenzl TG, North American Society for Pediatric Gastroenterology Hepatology and Nutrition, European Society for Pediatric Gastroenterology Hepatology and Nutrition. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr. 2009 Oct;49(4):498-547. doi: 10.1097/MPG.0b013e3181b7f563.
Zalzal GH, Tran LP. Pediatric gastroesophageal reflux and laryngopharyngeal reflux. Otolaryngol Clin North Am. 2000 Feb;33(1):151-61. doi: 10.1016/s0030-6665(05)70212-7.
Ali Mel-S. Laryngopharyngeal reflux: diagnosis and treatment of a controversial disease. Curr Opin Allergy Clin Immunol. 2008 Feb;8(1):28-33. doi: 10.1097/ACI.0b013e3282f3f44f.
Karkos PD, Leong SC, Apostolidou MT, Apostolidis T. Laryngeal manifestations and pediatric laryngopharyngeal reflux. Am J Otolaryngol. 2006 May-Jun;27(3):200-3. doi: 10.1016/j.amjoto.2005.09.004.
Al-Saab F, Manoukian JJ, Al-Sabah B, Almot S, Nguyen LH, Tewfik TL, Daniel SJ, Schloss MD, Hamid QA. Linking laryngopharyngeal reflux to otitis media with effusion: pepsinogen study of adenoid tissue and middle ear fluid. J Otolaryngol Head Neck Surg. 2008 Aug;37(4):565-71.
Contencin P, Maurage C, Ployet MJ, Seid AB, Sinaasappel M. Gastroesophageal reflux and ENT disorders in childhood. Int J Pediatr Otorhinolaryngol. 1995 Jun;32 Suppl:S135-44. doi: 10.1016/0165-5876(94)01157-s.
El-Serag HB, Gilger M, Kuebeler M, Rabeneck L. Extraesophageal associations of gastroesophageal reflux disease in children without neurologic defects. Gastroenterology. 2001 Dec;121(6):1294-9. doi: 10.1053/gast.2001.29545.
Yuksel F, Dogan M, Karatas D, Yuce S, Senturk M, Kulahli I. Gastroesophageal reflux disease in children with chronic otitis media with effusion. J Craniofac Surg. 2013 Mar;24(2):380-3. doi: 10.1097/SCS.0b013e31827feb08.
Nair S, Kumar M, Nair P. Role of GERD in children with otitis media with effusion. Indian J Pediatr. 2012 Oct;79(10):1328-32. doi: 10.1007/s12098-011-0671-y. Epub 2012 Jan 7.
Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs M, Kennedy DW, Lanza DC, Marple BF, Osguthorpe JD, Stankiewicz JA, Anon J, Denneny J, Emanuel I, Levine H. Adult chronic rhinosinusitis: definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg. 2003 Sep;129(3 Suppl):S1-32. doi: 10.1016/s0194-5998(03)01397-4. No abstract available.
Phipps CD, Wood WE, Gibson WS, Cochran WJ. Gastroesophageal reflux contributing to chronic sinus disease in children: a prospective analysis. Arch Otolaryngol Head Neck Surg. 2000 Jul;126(7):831-6. doi: 10.1001/archotol.126.7.831.
Lupa M, DelGaudio JM. Evidence-based practice: reflux in sinusitis. Otolaryngol Clin North Am. 2012 Oct;45(5):983-92. doi: 10.1016/j.otc.2012.06.004. Epub 2012 Aug 9.
Loehrl TA, Smith TL, Darling RJ, Torrico L, Prieto TE, Shaker R, Toohill RJ, Jaradeh SS. Autonomic dysfunction, vasomotor rhinitis, and extraesophageal manifestations of gastroesophageal reflux. Otolaryngol Head Neck Surg. 2002 Apr;126(4):382-7. doi: 10.1067/mhn.2002.123857.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4225
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.