Back to results

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

Primary Purpose

Allergic Rhinitis

Status

Unknown status

Phase

Phase 4

Locations

Pakistan

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Allergic Rhinitis focused on measuring Allergic Rhinitis in children, Montelukast, Intranasal Fluticasone Propionate

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intranasal Fluticasone Propionate Group

Montelukast Group

Arm Description

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

Montelukast 4mg oral granule formulation 24 hourly

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04957927

First Posted

July 1, 2021

Last Updated

July 1, 2021

Sponsor

Usama Azhar

Collaborators

King Edward Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04957927

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 12, 2020 (Actual)

Primary Completion Date

September 12, 2021 (Anticipated)

Study Completion Date

December 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Usama Azhar

Collaborators

King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Our study will compare the Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age as in our population compliance with oral medication is better among patients, and is socially and culturally more acceptable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Allergic Rhinitis in children, Montelukast, Intranasal Fluticasone Propionate

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Model Description

Randomized control trial

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intranasal Fluticasone Propionate Group

Arm Type

Experimental

Arm Description

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

Arm Title

Montelukast Group

Arm Type

Experimental

Arm Description

Montelukast 4mg oral granule formulation 24 hourly

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Usama Azhar, MBBS

Phone

0923336506169

dr.usama.azhar@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Muhammad Haroon Hamid, MBBS,FCPS

Phone

0923008880916

profharoon@kemu.edu.pk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Haroon Hamid, MBBS,FCPS,FRCS

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54000

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Usama Azhar, MBBS

Phone

0923336506169

First Name & Middle Initial & Last Name & Degree

Muhammad Haroon Hamid, MBBS,FCPS,FRCS

Phone

0923008880916

profharoon@kemu.edu.pk

First Name & Middle Initial & Last Name & Degree

Usama Azhar, MBBS

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

31333340

Citation

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.

Results Reference

background

PubMed Identifier

30128063

Citation

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.

Results Reference

background

PubMed Identifier

30473712

Citation

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.

Results Reference

background

PubMed Identifier

29079387

Citation

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.

Results Reference

background

PubMed Identifier

27656477

Citation

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.

Results Reference

background

PubMed Identifier

25644617

Citation

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.

Results Reference

background

PubMed Identifier

24618303

Citation

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.

Results Reference

background

PubMed Identifier

26396949

Citation

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.

Results Reference

background

PubMed Identifier

23952296

Citation

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.

Results Reference

background

PubMed Identifier

23429039

Citation

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.

Results Reference

background

PubMed Identifier

20804465

Citation

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.

Results Reference

background

PubMed Identifier

22053307

Citation

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. Erratum In: Asia Pac Allergy. 2012 Jan;2(1):90. Hadjojo, Antony [corrected to Hardjojo, Antony].

Results Reference

background

PubMed Identifier

19943707

Citation

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.

Results Reference

background

PubMed Identifier

12775135

Citation

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.

Results Reference

background

PubMed Identifier

12086367

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs