Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: Fixed Dose Combinations of Fluticasone 250 μg Plus Formoterol 12 μg as DPI: 1 puff twice daily for 12 weeks
Control Intervention1: Fluticap 250 μg & Foradil 12 μg as separate DPIs:
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 known history of moderate-severe persistent, reversible asthma for >= 6 months. 3. FEV1 between >=40% to 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. Females of child bearing age must have a negative pregnancy test at screening visit, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study.
Exclusion criteria
Exclusion criteria: 1. Inability to carry out pulmonary function testing 2. Significant, non-reversible, active pulmonary disease 3. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients 4. History of near fatal asthma within the past one year 5. Evidence of severe asthma exacerbation or upper or lower respiratory tract infections within the past 4 weeks 6. Active smoker 7. 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 8. Clinically significant cardiovascular, haematological, endocrine, neurological, gastrointestinal, psychiatric, metabolic, immunologic, infectious, hepatic, renal, gynaecological disease or other condition that the investigator considers detrimental to the patientâ??s participation in the study or that may prevent the successful completion of the study 9. History of uncontrolled Diabetes mellitus 10. Clinically significant ECG Abnormality at baseline 11. Use of prohibited medication 12. Patients who received any investigational new drug within the last 3 months
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