Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age

NCT04957927 | Unknown Phase 4 DMC

• 1 other identifier: 747/RC/KEMU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age.

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis in children; Montelukast; Intranasal Fluticasone Propionate

Outcome Measures

Primary Outcomes (1)

• Improvement in Day and Night time nasal symptoms score of Allergic Rhinitis

  Effectiveness will be assessed by noticing the Improvement in Day and Night time nasal symptoms score of Allergic Rhinitis.

  2 months

Study Arms (2)

Intranasal Fluticasone Propionate Group

EXPERIMENTAL

Intranasal Fluticasone Propionate 50mcg/actuation in each nostril 24 hourly

Drug: Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age

Montelukast Group

EXPERIMENTAL

Montelukast 4mg oral granule formulation 24 hourly

Drug: Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age

Interventions

Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age DRUG

Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age

Intranasal Fluticasone Propionate Group; Montelukast Group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age:02 to 05 Years of Age
• both genders will be included.
• patients diagnosed with allergic rhinitis.

You may not qualify if:

• patients older than 05 years of age
• 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.

Sponsors & Collaborators

• Usama Azhar: lead
• King Edward Medical University: collaborator

Study Sites (1)

King Edward Medical University/Mayo hospital lahore,punjab,pakistan 54000

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (15)

• 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.

  PMID: 31333340 BACKGROUND

• 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.

  PMID: 30128063 BACKGROUND

• 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.

  PMID: 30473712 BACKGROUND

• 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.

  PMID: 29079387 BACKGROUND

• 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.

  PMID: 27656477 BACKGROUND

• 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.

  PMID: 25644617 BACKGROUND

• 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.

  PMID: 24618303 BACKGROUND

• 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.

  PMID: 26396949 BACKGROUND

• 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.

  PMID: 23952296 BACKGROUND

• 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.

  PMID: 23429039 BACKGROUND

• 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.

  PMID: 20804465 BACKGROUND

• 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.

  PMID: 22053307 BACKGROUND

• 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.

  PMID: 19943707 BACKGROUND

• 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.

  PMID: 12775135 BACKGROUND

• 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.

  PMID: 12086367 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Muhammad Haroon Hamid, MBBS,FCPS,FRCS

  Chairman/Head of Department of pediatrics unit 1 K.E. Medical University/Mayo hospital lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Usama Azhar, MBBS

CONTACT

0923336506169; dr.usama.azhar@gmail.com

Muhammad Haroon Hamid, MBBS,FCPS

CONTACT

0923008880916; profharoon@kemu.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Resident in Pediatrics(MD Pediatrics)

Model Details: Randomized control trial

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 12, 2021
• Study Start: December 12, 2020
• Primary Completion: September 12, 2021
• Study Completion: December 12, 2021
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

PA (1)