Health Condition 1: J454- Moderate persistent asthma
Conditions
Interventions
Intervention1: Beclomethasone pMDI: Beclomethasone pMDI 250 mcg 2 inhalations twice a day for 4 weeks.
Control Intervention1: Budesonide/Formoterol pMDI: Budesonide/Formoterol pMDI 200/6 mcg 1 inhalat
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with Bronchial asthma receiving SABAs for at least three days in the last week. 2. Mild to Moderate bronchial asthma with post-bronchodilator FEV1 ( >80%) and Reversibility ( >12%)
Exclusion criteria
Exclusion criteria: 1. Patients with 2. Smoking or Non-smoking Risk factors including exposure to Biomass or Occupational hazard exposure 3. Patients on LTRAs &/or antihistamine combinations 4. Patients with hospitalization in the last four weeks for Uncontrolled asthma or requiring inhaled SABA of >=6 dosages in a day for the last week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intergroup difference in both arms for patients requiring Rescue medications at 4th weekTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment emergent adverse drug reactions at 4 weeks. 2. Post bronchodilator FEV1 change at 4 weeks for both arms. 3. Clinical responders (GINA score 1) from baseline at 4 weeks for both arms.Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr K Krishnaprasad
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed