Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: Budesonide 200 μg in HFA propelled MDI: 2 puffs twice daily for 12 weeks
Control Intervention1: Clenil® HFA 250 μg: 2 puffs twice daily for 12 weeks
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient and/or legally accepted representative (LAR) provides written informed consent to participate in the study 2. Male or female patient aged between 16 to 70 years with clinical diagnosis of stable persistant asthma 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 and also willing to document symptoms in diary. 5. Positive response to the reversibility test 6. Females of child bearing age must have a negative urine pregnancy test recorded at the screening visit, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study and at least 2 weeks post treatment if they are sexually active
Exclusion criteria
Exclusion criteria: 1. Inability to carry out pulmonary function testing 2. Diagnosis of 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 6. Evidence of severe asthma exacerbation in the previous 4 weeks or acute upper or lower respiratory tract infections within the past 2 weeks 7. Patients with eye disorders like cataract, glaucoma and herpes virus infection 8. Active smoker 9. Subjects who are using any medication or have any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study 10. 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. 11. History of uncontrolled Diabetes mellitus 12. Clinically significant ECG Abnormality at baseline 13. Patients with documented or suspected or current history of alcohol and drug abuse 14. Known history of HPA axis disease or malfunctioning 15. Use of prohibited medication 16. 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