Intermittent Budesonide-Formoterol versus Daily Budesonide for Mild Asthma in Children aged 6 to 11 years

Intermittent Budesonide-Formoterol versus Daily Budesonide for Mild Asthma in Children aged 6 to 11 years- A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102452

Enrollment

134

Registered

2026-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: J453- Mild persistent asthma

Interventions

Intervention1: Placebo and Budesonide-Formoterol: Inhaled Placebo 1 puff twice daily plus as needed inhaled Budesonide/formoterol (100/6 microgram) 2 puffs as needed (max 8 puffs) for 3 months Control

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 years to 11 years with new diagnosis of Asthma, who stratify in step 1 or 2 (symptoms up to 5 days/week, no night-time awakening), according to GINA 2025 Newly diagnosed asthma in children aged 6-11 years as per GINA 2025 guidelines(1) who stratify in step 1 or 2 - Symptoms up to 5 days/week No night-time awakening

Exclusion criteria

Exclusion criteria: -Child already on asthma medications -Children with other chronic lung diseases Bronchopulmonary dysplasia, congenital thoracic malformations, airway malacia, mucociliary clearance defects, Tuberculosis, Allergic bronchopulmonary aspergillosis Children with frequent or recent exacerbations of asthma in the past 4 weeks

Design outcomes

Primary

Measure	Time frame
To compare asthma control at 3 months between two groups using ACQ scoreTimepoint: 3 months	—

Secondary

Measure	Time frame
1. To compare the number of asthma exacerbations requiring steroids/hospital admissions between two groupsTimepoint: 3 months;2. To compare time to first exacerbation between two groupsTimepoint: 3 months;3. To compare cumulative dosage of ICS used between two groupsTimepoint: 3 months;4. To compare the cost efficacy between two groupsTimepoint: 3 months;5. To compare Quality of life between two groupsTimepoint: 3 months;6. To compare frequency of adverse events between two groupsTimepoint: 3 months	—

Measure

Time frame

1. To compare the number of asthma exacerbations requiring steroids/hospital admissions between two groupsTimepoint: 3 months;2. To compare time to first exacerbation between two groupsTimepoint: 3 months;3. To compare cumulative dosage of ICS used between two groupsTimepoint: 3 months;4. To compare the cost efficacy between two groupsTimepoint: 3 months;5. To compare Quality of life between two groupsTimepoint: 3 months;6. To compare frequency of adverse events between two groupsTimepoint: 3 months

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Countries

India

Contacts

Public ContactKkomal C Suvarna

ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR

kkcvsuvarna@gmail.com9828990018

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026