Health Condition 1: J453- Mild persistent asthma
Conditions
Interventions
Intervention1: Inhaled corticosteroid plus Formoterol: As needed Low dose Inhaled Corticosteroids (100 mcg) along with Formoterol (6 mcg) 2 puff by MDI for 6 months
Control Intervention1: One group: I
Sponsors
Rashmi Ranjan Das
Eligibility
Inclusion criteria
Inclusion criteria: Mild asthma or requiring Step 2 asthma treatment as per GINA 2023 guideline
Exclusion criteria
Exclusion criteria: 1) History of hospitalization for �24 hrs for asthma in past 12 months 2) History of life threatening asthma requiring intensive care unit (ICU) admission 3) Use of ICS or LABA or Montelukast or sustained release Theophylline in past 6 months 4) History of known hypersensitivity or contraindication to any above drugs used 5) Behavioral or neuropsychiatry disorder 6) Use of systemic steroids in last 6 weeks 7) Unwilling to change the current asthma treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of asthma exacerbationsTimepoint: Number of asthma exacerbations | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of asthma exacerbations sTimepoint: 12 weeks ( 3 months);Time to first asthma exacerbationTimepoint: After enrollment till 6 months of follow up;Proportion of children with achievement of asthma control as assessed by C-ACT or ACTTimepoint: 12 & 24 weeks;Improvement in lung function test (FEV1)Timepoint: 12 & 24 weeks;Proportions of children needing any change or additional therapy (LABA or Montelukast)Timepoint: After enrollment till 6 months follow up;Cumulative dose of ICS usedTimepoint: 12 & 24 weeks;Quality of life (QoL)Timepoint: 12 & 24 weeks;Adverse eventsTimepoint: Entire study period including follow up;Cost effectivenessTimepoint: End of the study | — |
Countries
India
Contacts
Public ContactRashmi Ranjan Behera
AIIMS
Outcome results
None listed