Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Sponsor
Usama Azhar (Other)
Overall Status
Recruiting
CT.gov ID
NCT04957927
Collaborator
King Edward Medical University (Other)
60
1
2
12
5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Randomized control trialRandomized control trial
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
Actual Study Start Date
:
Dec 12, 2020
Anticipated Primary Completion Date
:
Sep 12, 2021
Anticipated Study Completion Date
:
Dec 12, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intranasal Fluticasone Propionate Group 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
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
|
| Experimental: Montelukast Group 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
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
|
Outcome Measures
Primary Outcome Measures
- Improvement in Day and Night time nasal symptoms score of Allergic Rhinitis [2 months]
Effectiveness will be assessed by noticing the Improvement in Day and Night time nasal symptoms score of Allergic Rhinitis.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | King Edward Medical University/Mayo hospital lahore,punjab,pakistan 54000 | Lahore | Punjab | Pakistan | 54000 |
Sponsors and Collaborators
- Usama Azhar
- King Edward Medical University
Investigators
- Principal Investigator: Muhammad Haroon Hamid, MBBS,FCPS,FRCS, Chairman/Head of Department of pediatrics unit 1 K.E. Medical University/Mayo hospital lahore
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- 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. Review.
- 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.
- 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].
- 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.
- 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.
- Mansi N, D'Agostino G, Scirè 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.
- 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. Review.
- 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.
- 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.
- 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.
- 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. Review.
- 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.
Responsible Party:
Usama Azhar,
Post Graduate Resident in Pediatrics(MD Pediatrics),
King Edward Medical University
ClinicalTrials.gov Identifier:
NCT04957927
Other Study ID Numbers:
- 747/RC/KEMU
First Posted:
Jul 12, 2021
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Usama Azhar,
Post Graduate Resident in Pediatrics(MD Pediatrics),
King Edward Medical University
Additional relevant MeSH terms: