Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Fluticasone furoate/vilanterol (100/25 µg and 200/25 µg ) via dry powder inhaler: 1 capsule to be inhaled daily for 12 Weeks.
Control Intervention1: Nil: Nil
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged more than or equal to 12 years with a documented diagnosis of asthma 2. Pre-bronchodilator FEV1 of 40-90% predicted normal 3. Symptomatic patients receiving ongoing treatment with either ICS-SABA or ICS LABA or SMART 4. ACQ-5 score more than or equal to 1.5 at baseline. 5. Patient/parent/legal guardian willing to give a written informed consent/parental consent/assent form. 6. Able to/Willing to strictly adhere to the investigator’s prescription
Exclusion criteria
Exclusion criteria: 1. History of current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition). 2. Smoking history of more than 10 pack-years 3. Women of childbearing potential are not restricted in this study, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment. 4. Patients who have participated in any clinical trial within 30 days prior to enrolment and would not be participating in clinical study during the period of study participation. 5. History of known hypersensitivity to any individual study drug of the study drug combination or to any of the excipient present in the dosage form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of patients with asthma in India treated with FF/VI in terms of - • Number of patients with any drug related treatment emergent adverse events (TEAEs). [Time frame: up to Week 12] • Number of patients with TEAEs [Time Frame: up to Week 12] • Number of patients with serious TEAEs (STEAEs) [Time Frame: up to Week 12] Timepoint: Up to 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Trough FEV1 from baseline. Mean change in ACQ-5 score from baseline. Proportion of patients requiring hospitalization Rescue medication use averaged over 12weeks of treatment. Compliance with the study medication. Assessment of patient satisfaction with the treatment. Assessment of physician satisfaction with the treatment Timepoint: Up to 12 Weeks | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed