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

NCT02278081 | Unknown Phase 4

• 1 other identifier: 4225
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinitis; Nasal Obstruction; GERD

Keywords

Rhinitis (nasal obstruction) and GERD

Outcome Measures

Primary Outcomes (1)

• 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 .

  three months

Study Arms (2)

treatment group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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

Interventions

lansoprazole DRUG

the lansoprazole will be taken orally.

treatment group

placebo DRUG

the lansoprazole placebo will be taken orally.

placebo group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• (seven) to 17 (seventeen) years of age.
• Nasal obstruction as main complaint.

You may not qualify if:

• Structural cause of nasal obstruction (deviated nasal septum, adenoid hypertrophy, nasal polyps, nasal tumors)
• Received antireflux medication during the last three months.
• Acute sinusitis

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Related Publications (13)

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  PMID: 19745761 BACKGROUND

• 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.

  PMID: 10637349 BACKGROUND

• 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.

  PMID: 18188014 BACKGROUND

• 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.

  PMID: 16647985 BACKGROUND

• 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.

  PMID: 19128594 BACKGROUND

• 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.

  PMID: 7665283 BACKGROUND

• 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.

  PMID: 11729108 BACKGROUND

• 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.

  PMID: 23524698 BACKGROUND

• 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.

  PMID: 22227976 BACKGROUND

• 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.

  PMID: 12958561 BACKGROUND

• 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.

  PMID: 10888994 BACKGROUND

• 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.

  PMID: 22980679 BACKGROUND

• 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.

  PMID: 11997777 BACKGROUND

MeSH Terms

Conditions

Rhinitis; Nasal Obstruction; Gastroesophageal Reflux

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

John J Manoukian, MD, FRCSC, FACS

CONTACT

( 514 ) 412-4400; john.manoukian@mcgill.ca

Abdullah A Alarfaj, MD.

CONTACT

514 582-3229; abdullah.alarfaj@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Faculty of Medicine, McGill University, Department of Otolaryngology-Head and Neck Surgery

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 29, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 29, 2014

Record last verified: 2014-10