Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: Beclomethasone Dipropionate, HFA propelled MDI: 2 puffs, twice daily for 12 Weeks
Control Intervention1: Clenil®, HFA propelled MDI: 2 puffs, twice daily for 12 Weeks
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged between 18 to 70 years with clinical diagnosis of mild to moderate asthma 2. The patient provides written informed consent to participate in the study 3. FEV1 between 60% and 80% of the predicted value 4. Patient willing to perform all study related procedures including the use of study inhalers, spirometer and peak flow meter. 5. Positive response to the reversibility test 6. Negative urine pregnancy test at screening visit, in women of child bearing age group and willing to use acceptable contraceptive measures during the study period or women who have been permanently sterilized or attained menopause. Male patients should use double barrier contraceptive measures
Exclusion criteria
Exclusion criteria: 1. Inability to carry out pulmonary function testing 2. Chronic Obstructive Pulmonary Disease (COPD) 3. Pregnant or lactating women 4. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients 5. History of near fatal asthma exacerbation 6. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks 7. Active smoker 8. Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study 9. Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, endocrinal, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma 10. History of Diabetes mellitus 11. Clinically significant ECG Abnormality at baseline 12. History of alcohol or drug abuse 13. Known history of HPA axis disease or malfunctioning 14. Patients who have undergone major surgery in the previous 4 weeks 15. Participation in an investigational drug trial within 3 months of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference between groups in FEV1 value at the End of Treatment VisitTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Average need for use of short acting β 2 agonistsTimepoint: 12 weeks;Change in asthma symptom scoreTimepoint: 12 weeks;Change in Diurnal variability of PEFTimepoint: 12 weeks;Change in evening PEFTimepoint: 12 weeks;Change in morning PEFTimepoint: 12 weeks;Change in nocturnal asthma symptomTimepoint: 12 weeks;Number of asthma exacerbationsTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Shailendra Sachan
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed