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A Study Which Compares Two Different Doses Of A Drug To Treat Sudden Breathing Difficulty Due To Asthma

A 3-day course of 1 versus 2 milligram per Kilogram body weight oral prednisolone for 1-5 yr old children with acute moderate exacerbation of asthma: a randomized double blind non inferiority trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009297
Enrollment
128
Registered
2017-08-08
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- Acute moderate exacerbation of bronchial asthma

Interventions

Intervention1: oral prednisolone 1mg/kg single dose For 3 Days: single dose of oral prednisolone 1mg/kg For 3 Days Control Intervention1: comparator agent is oral prednisolone single dose 2 mg/kg For

Sponsors

Jawaharlal Institute Of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children aged 1-5 years with more than 2 episodes of physician diagnosed wheeze and EITHER i) a physician documented improvement in signs with short acting beta agonist (SABA) therapy with or without oral corticosteroids OR ii) Convincing parental report of symptomatic response to a three month trial of medium dose inhaled corticosteroids with or without SABA AND with moderate exacerbation assessed with PRAM score (score >=4 to

Exclusion criteria

Exclusion criteria: . Exclusion criteria Clinical evidence of other known chronic respiratory conditions - both suppurative and non suppurative (bronchiectasis, cystic fibrosis, congenital airway anomalies) History suggestive of recurrent aspiration in the past Clinical suspicion of pneumonia Children with congenital heart disease Children with failure to thrive Children already on oral prednisolone, monteleukast or azithromycin therapy Children with poor oral intake, drowsiness or vomiting Children with features suggestive of life threatening asthma

Design outcomes

Primary

MeasureTime frame
Proportion Of Children With PRAM score less than 4 at 4 hours after intervention Timepoint: PRAM score Hourly for the first 4 hours followed by 8 , 24, 48 and 72 hours

Secondary

MeasureTime frame
Proportion of children requiring escalation of treatment , Proportion requiring readmission within 7 days Side effect profile between the two groups Timepoint: 7 days

Countries

India

Contacts

Public ContactDr Venkatesh Chandrasekaran

JAWAHARLAL INSTITUTE OF PG MEDICAL EDUCATION AND RESEARCH

cvenkatesh@hotmail.com9842534154

Outcome results

None listed

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