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study of monteleukast and budesonide in asthma

COMPARISION BETWEEN ORAL MONTELUKAST AND INHALED BUDESONIDE AS A FIRST LINE PREVENTIVE THERAPY IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA IN THE AGE GROUP OF 2-18YRS. A PROSPECTIVE RANDOMIZED CLINICAL STUDY

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/11/003148
Enrollment
60
Registered
2012-11-26
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- asthma

Interventions

Intervention1: monteleukast: Patients will be given Monteleukast 4mg tablet (up to 5 yr) and 5mg (5 yr) as once daily night time dosage for 12 weeks Control Intervention1: budesonide: Patients will be

Sponsors

Department of pediatrics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 2-18 yr coming as outpatients or admitted as inpatients in department of paediatrics Sir Takhtsinhji Hospital, Bhavnagar. 2. Diagnosed as mild persistent asthma as per GINA(Global initiative for asthma) guidelines.

Exclusion criteria

Exclusion criteria: 1. Age 2. Patients who had history of attack of status asthmaticus in past 4 weeks 3. Patients who had taken any of the following drugs in past 4 weeks • Long acting beta agonists • Chromolyn sodium • Nedocromil sodium • Theophylin 4. Patients having any of the following diseases: • Tuberculosis • Pneumonia • Chronic sinusitis • Foreign body aspiration • Congenital Heart Diseases • Congenital anomalies of respiratory tract, i.e. laryngomalecia. • Tropical Pulmonary Eosinophilia • Roundworm Infestation

Design outcomes

Primary

MeasureTime frame
frequency of symptoms, nocturnal worsening, frequency of use of short acting beta agonists and/or oral steroids occurrence of side effects and pulmonary function testTimepoint: 1week 2week 4week 8week 12week

Secondary

MeasureTime frame
change of medicationsTimepoint: 6 months

Countries

India

Contacts

Public Contactdr jayendra r gohil

government medical college bhavnagar

jayukids@yahoo.com9824090049

Outcome results

None listed

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