A Phase 2 interventional study of Montelukast and Placebo in Acute Bronchiolitis, sponsored by Pakistan Institute of Medical Sciences. Recruiting at 1 site in Pakistan. Open to participants aged 4 Weeks to 2 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Pakistan Institute of Medical Sciences · Phase 2, Interventional, and Treatment
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
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 195 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Pakistan Institute of Medical Sciences is the lead sponsor of 55 studies on the registry; 25 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive montelukast 4 mg sachet orally once daily at night in addition to standard supportive care for acute bronchiolitis.
Drug: Montelukast
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
Administrating montelukast to experimental group and monitoring response
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
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
Time frame: Baseline (hospital admission) and 72 hours after initiation of treatment
Length of Hospital Stay
Length of hospital stay measured in hours from hospital admission until hospital discharge. Discharge is defined by resolution of symptoms, including improved feeding, absence of respiratory distress, a clinical severity score less than 3, and respiratory rate within the normal range for age.
Time frame: From baseline (hospital admission;day 1) through hospital discharge ( day 7)
Plan to share: No — Individual participant data will not be shared outside the primary research team because of participant privacy and confidentiality considerations.
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Studies of the drug tested here: Montelukast
Pakistan Institute of Medical Sciences