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

GERD Clinical Trial

— Pale Turbinate  

Official title:

The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate. A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02278081
• Other study ID #: 4225
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 21, 2014
• Last updated: October 27, 2014
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2014
• Source: McGill University Health Center
• Contact: John J Manoukian, MD, FRCSC, FACS
• Phone: ( 514 ) 412-4400
• Email: john.manoukian[@]mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD
• Nasal Obstruction
• Rhinitis

Intervention

Drug:
• lansoprazole
the lansoprazole will be taken orally.
• placebo
the lansoprazole placebo will be taken orally.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

References & Publications (13)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Karkos PD, Leong SC, Apostolidou MT, Apostolidis T. Laryngeal manifestations and pediatric laryngopharyngeal reflux. Am J Otolaryngol. 2006 May-Jun;27(3):200-3. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yüksel F, Dogan M, Karatas D, Yüce S, Sentürk M, Külahli 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. — View Citation

Zalzal GH, Tran LP. Pediatric gastroesophageal reflux and laryngopharyngeal reflux. Otolaryngol Clin North Am. 2000 Feb;33(1):151-61. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No