Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
NCT ID: NCT04957927
Last Updated: 2021-07-12
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
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2020-12-12
2021-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intranasal Fluticasone Propionate Group
Intranasal Fluticasone Propionate 50mcg/actuation in each nostril 24 hourly
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Montelukast Group
Montelukast 4mg oral granule formulation 24 hourly
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Interventions
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Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Eligibility Criteria
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Inclusion Criteria
* both genders will be included.
* patients diagnosed with allergic rhinitis.
Exclusion Criteria
* a positive history of HIV,TB,Immune deficiency.
* any nasal structural abnormality i.e.polyps,deviated nasal septum.
* history of frequent nasal bleeding,epistaxis.
* concomitant asthma.
2 Years
5 Years
ALL
No
Sponsors
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King Edward Medical University
OTHER
Usama Azhar
OTHER
Responsible Party
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Usama Azhar
Post Graduate Resident in Pediatrics(MD Pediatrics)
Principal Investigators
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Muhammad Haroon Hamid, MBBS,FCPS,FRCS
Role: PRINCIPAL_INVESTIGATOR
Chairman/Head of Department of pediatrics unit 1 K.E. Medical University/Mayo hospital lahore
Locations
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King Edward Medical University/Mayo hospital lahore,punjab,pakistan 54000
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Usama Azhar, MBBS
Role: primary
References
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Emeryk A, Emeryk-Maksymiuk J, Janeczek K. New guidelines for the treatment of seasonal allergic rhinitis. Postepy Dermatol Alergol. 2019 Jun;36(3):255-260. doi: 10.5114/ada.2018.75749. Epub 2019 Jun 18.
Chong SN, Chew FT. Epidemiology of allergic rhinitis and associated risk factors in Asia. World Allergy Organ J. 2018 Aug 6;11(1):17. doi: 10.1186/s40413-018-0198-z. eCollection 2018.
Al-Digheari A, Mahboub B, Tarraf H, Yucel T, Annesi-Maesano I, Doble A, Lahlou A, Tariq L, Aziz F, El Hasnaoui A. The clinical burden of allergic rhinitis in five Middle Eastern countries: results of the SNAPSHOT program. Allergy Asthma Clin Immunol. 2018 Nov 19;14:63. doi: 10.1186/s13223-018-0298-x. eCollection 2018.
May JR, Dolen WK. Management of Allergic Rhinitis: A Review for the Community Pharmacist. Clin Ther. 2017 Dec;39(12):2410-2419. doi: 10.1016/j.clinthera.2017.10.006. Epub 2017 Oct 25.
Jindal A, Suriyan S, Sagadevan S, Narasimhan M, Shanmuganathan A, Vallabhaneni V, Rajalingam R. Comparison of Oral Montelukast and Intranasal Fluticasone in Patients with Asthma and Allergic Rhinitis. J Clin Diagn Res. 2016 Aug;10(8):OC06-10. doi: 10.7860/JCDR/2016/20741.8268. Epub 2016 Aug 1.
Seidman MD, Gurgel RK, Lin SY, Schwartz SR, Baroody FM, Bonner JR, Dawson DE, Dykewicz MS, Hackell JM, Han JK, Ishman SL, Krouse HJ, Malekzadeh S, Mims JW, Omole FS, Reddy WD, Wallace DV, Walsh SA, Warren BE, Wilson MN, Nnacheta LC; Guideline Otolaryngology Development Group. AAO-HNSF. Clinical practice guideline: Allergic rhinitis. Otolaryngol Head Neck Surg. 2015 Feb;152(1 Suppl):S1-43. doi: 10.1177/0194599814561600.
Goh BS, Ismail MI, Husain S. Quality of life assessment in patients with moderate to severe allergic rhinitis treated with montelukast and/or intranasal steroids: a randomised, double-blind, placebo-controlled study. J Laryngol Otol. 2014 Mar;128(3):242-8. doi: 10.1017/S002221511400036X. Epub 2014 Mar 11.
Mansi N, D'Agostino G, Scire AS, Morpurgo G, Gregori D, Gulati A, Damiani V. Allergic Rhinitis in Children: A Randomized Clinical Trial Targeted at Symptoms. Indian J Otolaryngol Head Neck Surg. 2014 Dec;66(4):386-93. doi: 10.1007/s12070-014-0708-4. Epub 2014 Feb 11.
Roberts G, Xatzipsalti M, Borrego LM, Custovic A, Halken S, Hellings PW, Papadopoulos NG, Rotiroti G, Scadding G, Timmermans F, Valovirta E. Paediatric rhinitis: position paper of the European Academy of Allergy and Clinical Immunology. Allergy. 2013 Sep;68(9):1102-16. doi: 10.1111/all.12235. Epub 2013 Aug 19.
Ologe FE, Adebola SO, Dunmade AD, Adeniji KA, Oyejola BA. Symptom score for allergic rhinitis. Otolaryngol Head Neck Surg. 2013 Apr;148(4):557-63. doi: 10.1177/0194599813477605. Epub 2013 Feb 21.
Herr M, Clarisse B, Nikasinovic L, Foucault C, Le Marec AM, Giordanella JP, Just J, Momas I. Does allergic rhinitis exist in infancy? Findings from the PARIS birth cohort. Allergy. 2011 Feb;66(2):214-21. doi: 10.1111/j.1398-9995.2010.02467.x. Epub 2010 Aug 30.
Hardjojo A, Shek LP, van Bever HP, Lee BW. Rhinitis in children less than 6 years of age: current knowledge and challenges. Asia Pac Allergy. 2011 Oct;1(3):115-22. doi: 10.5415/apallergy.2011.1.3.115. Epub 2011 Oct 11.
Phan H, Moeller ML, Nahata MC. Treatment of allergic rhinitis in infants and children: efficacy and safety of second-generation antihistamines and the leukotriene receptor antagonist montelukast. Drugs. 2009;69(18):2541-76. doi: 10.2165/9884960-000000000-00000.
Ratner PH, Howland WC 3rd, Arastu R, Philpot EE, Klein KC, Baidoo CA, Faris MA, Rickard KA. Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast. Ann Allergy Asthma Immunol. 2003 May;90(5):536-42. doi: 10.1016/S1081-1206(10)61847-9.
Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600. doi: 10.1016/S1081-1206(10)61891-1.
Other Identifiers
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747/RC/KEMU
Identifier Type: -
Identifier Source: org_study_id
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