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

July 1, 2021 updated by: Usama Azhar
To determine the Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • King Edward Medical University/Mayo hospital lahore,punjab,pakistan 54000
        • Contact:
          • Usama Azhar, MBBS
          • Phone Number: 0923336506169
        • Contact:
        • Sub-Investigator:
          • Usama Azhar, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Day and Night time nasal symptoms score of Allergic Rhinitis
Time Frame: 2 months
Effectiveness will be assessed by noticing the Improvement in Day and Night time nasal symptoms score of Allergic Rhinitis.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Usama Azhar

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2020

Primary Completion (Anticipated)

September 12, 2021

Study Completion (Anticipated)

December 12, 2021

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 747/RC/KEMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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