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

Phase 4

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

• Registration Number: NCT04957927
• Lead Sponsor: Usama Azhar

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.

Study Timeline

• Study Start: 2020-12-12
• Status Verified: 2021-07
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12
• Primary Completion: 2021-09-12
• Study Completion: 2021-12-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intranasal Fluticasone Propionate Group	Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age	Intranasal Fluticasone Propionate 50mcg/actuation in each nostril 24 hourly
Montelukast Group	Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age	Montelukast 4mg oral granule formulation 24 hourly

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

King Edward Medical University/Mayo hospital lahore,punjab,pakistan 54000; 🇵🇰 Lahore, Punjab, Pakistan