Evaluating The Role Of Montelukast In Management Of Acute Bronchiolitis

NCT07770464 | Recruiting Phase 2

• 1 other identifier: Bronchiolitis9699
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the role of Montelukast in management of acute Bronchiolitis in indoor patient and how this drug shortens the duration of admission and improves symptoms

Conditions

Acute Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Severity Score from Baseline to 72 Hours

  Change in the study-defined Clinical Severity Score from baseline at hospital admission to 72 hours after initiation of treatment. The score ranges from 0 to 12 and is calculated from heart rate, wheezing, respiratory rate, dyspnea, respiratory support, and feeding difficulties, with each component scored from 0 to 2. Higher scores indicate greater clinical severity. The change in score will be compared between the montelukast and placebo groups

  Baseline (hospital admission) and 72 hours after initiation of treatment

Secondary Outcomes (1)

• Length of Hospital Stay

  From baseline (hospital admission;day 1) through hospital discharge ( day 7)

Study Arms (2)

Montelukast

EXPERIMENTAL

Participants will receive montelukast 4 mg sachet orally once daily at night in addition to standard supportive care for acute bronchiolitis.

Drug: Montelukast

Control

PLACEBO COMPARATOR

Participants will receive placebo sugar granules orally once daily at night according to the same schedule as the montelukast group, in addition to standard supportive care for acute bronchiolitis

Drug: Placebo

Interventions

Montelukast DRUG

Administrating montelukast to experimental group and monitoring response

Montelukast

Placebo DRUG

Placebo sugar granules administered orally once daily at night according to the same schedule as montelukast 4 mg sachet, in addition to standard supportive care for acute bronchiolitis

Control

Eligibility Criteria

• Age: 4 Weeks - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4 weeks to 2 years
• Both genders
• Duration of respiratory symptoms less than 4 days
• Clinical diagnosis of acute bronchiolitis according to the operational definition provided in the study protocol

You may not qualify if:

• History of asthma
• Previous hospital admissions for respiratory illness
• Use of asthma medications
• Congenital heart disease
• Bronchopulmonary dysplasia
• Immunodeficiency
• Immunosuppression
• Radiological evidence of pneumonia, including infiltrates or patches on chest X-ray

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Pakistan Institute of Medical Sciences, Islamabad

Islamabad, Federal, 44000, Pakistan

RECRUITING

MeSH Terms

Interventions

montelukast

Study Officials

• Dr Haniyah Anwar

  Pakistan Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Haniyah Anwar, M.B.B.S

CONTACT

+92334-8359647; haniyahanwar@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Trainee, Children Hospital, PIMS

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 18, 2026
• Study Start: January 1, 2026
• Primary Completion: September 30, 2026
• Study Completion: September 30, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)