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MART versus ICS/LABA plus as-needed salbutamol in children 6-11 years with step 3 asthma

Budesonide/formoterol Maintenance and Reliever Therapy (MART) versus budesonide/formoterol plus as-needed salbutamol in children 6-11 years with asthma: A Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100519
Enrollment
98
Registered
2026-01-08
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: Very low dose MART: 100mcg Budesonide + formoterol Once daily + as needed Budesonide + formoterol (total maximum 8 puffs/day)
total duration 3 months Control Intervention1: Fixed low dose ICS+Laba + as needed SABA: 100mcg Budesonide + Formoterol twice daily dose + as needed Salbutamol
total duration 3 months

Sponsors

All India Institute of Medical Sciences Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: GINA step 3 asthma

Exclusion criteria

Exclusion criteria: Chronic lung disease ~ BPD Congenital thoracic malformations Airway malacia Mucociliary dysfunction- Cystic fibrosis, primary ciliary dyskinesia History of recent exacerbation requiring oral/IM/IV corticosteroid in last 4 weeks

Design outcomes

Primary

MeasureTime frame
Change in Asthma Control Questionnaire (ACQ) score in children on Budesonide/formoterol MART in comparison to fixed-dose Budesonide/formoterol plus as-needed salbutamol. Timepoint: 0, 1, 2 & 3 months—

Secondary

MeasureTime frame
Number of exacerbations Time to first exacerbation. Quality of life Improvement in lung function Cumulative dosage Adverse events Timepoint: 0, 1, 2, 3 months—

Countries

India

Contacts

Public ContactSathya Srivatsav

AIIMS Jodhpur

goyal.drjagdish@gmail.com8475000270

Outcome results

None listed

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