Home » Trials » SLCTR/2020/027


Effectiveness of oral montelukast Vs cetirizine in the management of allergic rhinitis in 6-12 -year -old children present to the asthma clinic at the Faculty of Medicine, University of Ruhuna. A randomized double blind controlled clinical trial

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SLCTR Registration Number

SLCTR/2020/027


Date of Registration

28 Dec 2020

The date of last modification

Dec 29, 2020



Application Summary


Scientific Title of Trial

Effectiveness of oral montelukast Vs cetirizine in the management of allergic rhinitis in 6-12 -year -old children present to the asthma clinic at the Faculty of Medicine, University of Ruhuna. A randomized double blind controlled clinical trial


Public Title of Trial

Effectiveness of oral montelukast vs cetirizine in the management of allergic rhinitis in 6-12 -year -old children present to the asthma clinic at the Faculty of Medicine , University of Ruhuna. A randomized double blind controlled clinical trial


Disease or Health Condition(s) Studied

Allergic rhinitis


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1261-3533


Any other number(s) assigned to the trial and issuing authority

2020/P/108 ERC Ruhuna


Trial Details


What is the research question being addressed?

Is oral montelukast more effective than cetirizine in the management of allergic Rhinitis in 6-12 -year -old children?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Investigators, Data analysts, Outcome assessors


Control

Active


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 4


Intervention(s) planned

The study will be done at the Asthma clinic, Faculty of Medicine, University of Ruhuna. Participants will be randomized to two groups using computer generated block randomizing. One group will be given cetirizine 10mg at night for three months with dummy tablet of montelukast, and the other will be given montelukast 5 mg at night for three months with a dummy tablet of cetirizine. Dummy tablets will be prepared for both medications- Montelukast (Montiget) and cetirizine (Alerid) similar in color and morphology to its real tablet. Each dummy tablet will contain lactose and starch Both groups will receive 2 tablets at a time; the drug and the dummy.


Inclusion criteria

  • Age 6- 12 years

  • Both male and female

  • Having 3 out of 4 of the following for more than six months [Sneezing, non purulent rhinorrhea, itchy nose, nasal congestion]

  • Moderately severe- Defined as having one or more of the following items [Sleep disturbance, Impairment of daily activities, leisure and/or sport, Impairment of school or work]

  • Along with troublesome symptoms. [itchy eyes, Itchy nose, itchy throat, runny nose, blocked nose, sneezing, tearing/red eyes, mouth breathing]


Exclusion criteria

  • Those who had taken treatment for allergic rhinitis (either oral treatment over last 2 weeks or intranasal treatment over the last 4 weeks)

  • Deformities of the nasal passages

  • Those who have undergone surgery in the upper airway.

  • Children with mild symptoms of allergic rhinitis. Mild defined as the having none of the following items present: [Sleep disturbance, Impairment of daily activities, leisure and/or sport, Impairment of school or work]

-Troublesome symptoms [itchy eyes, Itchy nose, itchy throat, runny nose, blocked nose, sneezing, tearing/red eyes, mouth breathing].

[Accompanied eye and ear symptoms of allergic rhino conjunctivitis or bronchial asthma or eczema will not be excluded]

  • Those who are on antacids and proton pump inhibitors (drug interactions)


Primary outcome(s)

1.

1.Nasal symptom scored according to a four point Likert scale

[

At the end of 3 months of starting treatment

]
2.

2.Quality of life using the Pediatric Rhino conjunctivitis Quality of Life Questionnaire (PRQLQ)

[

At the end of 3 months of starting treatment

]

Secondary outcome(s)

1.

None

[]

Target number/sample size

176 (88 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2020-12-28


Anticipated end date

2021-06-18


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Getz Pharma (pvt) Ltd, Cipla Pharma Lanka, Astron Limited, Hilton Pharma


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2020-10-22


Approval number

2020/P/108


Details of Ethics Review Committee

Name: ERC, Faculty of Medicine, University of Ruhuna
Institutional Address:ERC, Faculty of Medicine, University of Ruhuna P.O.Box70,Galle, Sri Lanka
Telephone:+094-091-2232288
Email: ethics@med.ruh.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Pushpika Prabashini Jayawardana
Senior Lecturer/ Pediatrician
Department of Pediatrics, Faculty of Medicine, University of Ruhuna, P.O.Box 70, Galle, Sri Lanka
+94 091 2246879
+94777901662
+094 091 2222314
pushpikaja@yahoo.com.au

Contact Person for Public Queries

Pushpika Prabashini Jayawardana
Senior Lecturer/ Pediatrician
Department of Pediatrics, Faculty of Medicine, University of Ruhuna, P.O.Box 70, Galle, Sri Lanka
+94 091 2246879
+94777901662
+094 091 2222314
pushpikaja@yahoo.com.au


Primary study sponsor/organization

Asthma clinic, Faculty of Medicine, University of Ruhuna





Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results