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usefulness of Monteleukast in acute asthma in children

Monteleukast for acute asthma exacerbation in children 5years -15 years- A randomized double blind placebo controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/01/005423
Enrollment
104
Registered
2015-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Childhood Asthma

Interventions

Intervention1: Montelukast in syrup: 10mg at 0hr and 24 hr for age below 12 yrs 20mg at 0 hr and 24 hr for age above12 yrs Control Intervention1: Placebo-syrup base identical in colour,taste and volum

Sponsors

Fluid research FundChristian Medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 5-15 completed years with a diagnosis of asthma presenting with mild to moderate acute exacerbation (modified pulmonary index score 5-11)

Exclusion criteria

Exclusion criteria: 1.Severe exacerbations with a modified pulmonary index score >12. 2.Children who have been already started on oral steroids for present exacerbation 3.Children on treatment with daily monteleukast in the last month 4.Children who cannot remain in hospital for atleast 4 hours from the onset of treatment.

Design outcomes

Primary

MeasureTime frame
Modified pulmonary index score 4 hours after study drug.Reduction in score will be compared with placebo armTimepoint: Modified Pulmonary Index Score(MPIS)measured at 0 hour and 4 hours.

Secondary

MeasureTime frame
Improvement in peak expiratory flow rateTimepoint: from baseline to 4 hours and 36 -48 hours;need for steroid useTimepoint: 4 hours and 36-49 hours;subjective improvement of symptoms using visual analog scaleTimepoint: from baseline to 4 hours and 36 -48

Countries

India

Contacts

Public ContactDr C Rahul Reddy

Christian Medical College, Vellore

snehatitus85@yahoo.com09488840434

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026