Health Condition 1: J452- Mild intermittent asthma Health Condition 2: J453- Mild persistent asthma Health Condition 3: J454- Moderate persistent asthma Health Condition 4: J459- Other and unspecified asthma Health Condition 5: J455- Severe persistent asthma
Conditions
Interventions
Intervention1: Inhaled Formoterol and Budesonide combination: One puff of Metered Dose Inhaler containing 100 or 200 micrograms of Budesonide and 6 micrograms of Formoterol to be given via inhalationa
Sponsors
All India Institute of Medical Sciences, Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children aged 6-18 years 2. Bronchial asthma requiring treatment as per GINA guidelines step 1 to 4 3. Ability to perform spirometry in accordance with the standards of the American Thoracic Society
Exclusion criteria
Exclusion criteria: 1. Co-existent other chronic pulmonary diseases 2. Chronic renal, gastrointestinal diseases, hepatic or cardiac diseases 3. History of active smoking 4. Patient who took a systemic corticosteroid within the previous 4 weeks 5. Prior PICU admission for asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of children with asthma showing improved asthma control questionnaire(ACQ) score between the two groupsTimepoint: 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the improvement in level of control of asthma, number and severity of exacerbations and time to first exacerbation on treatment in both groupsTimepoint: 24 weeks;To compare the proportion of children showing improved Pediatric Asthma Quality of life score(PAQLQ) between the two groupsTimepoint: 24 weeks;To compare the proportion of children with improved spirometric parameters between the two groupsTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactMeenu Singh
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed