Health Condition 1: J45- Asthma
Conditions
Interventions
Intervention1: Vilanterol 25 mcg and Fluticasone Furoate 200 mcg powder: 1 capsule to be inhaled daily for 12 Weeks. This capsule to be taken through Respihaler device. It should be administered at th
Sponsors
Zydus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex between 12 to 75 years of age (both inclusive) with a documented diagnosis of asthma 2. Pre-bronchodilator FEV1 of 40 percentage to 80 percentage of the predicted normal value at visit 1 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 or parent or legal guardian willing to give a written informed consent or parental consent or assent form. 6. Able to or Willing to strictly adhere to the investigators 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 other clinical trial within 30 days prior to enrolment and would not be participating in any other 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 |
|---|---|
| 1. Number of patients with any drug related treatment emergent adverse events (TEAEs) in time-frame up to 12 weeks 2. Number of patients with all TEAEs in time-frame up to 12 weeks 3. Number of patients with serious TEAEs in time-frame up to 12 weeksTimepoint: Up to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in trough FEV1 from baseline to 12 weeksTimepoint: Baseline (Visit 1 / Day 0) & End of study (Visit 4 / Week 12);Mean change in ACQ-5 score from baseline to 4 week, 8 week and 12 weeksTimepoint: Baseline (Visit 1 / Day 0), Visit 2 (Week 4), Visit 3 (Week 8) & End of study (Visit 4 / Week 12);Mean change in trough FVC from baseline to 12 weeksTimepoint: At baseline (Visit 1 / Day 0) & At End of study (Visit 4 / Week 12);Proportion of patients requiring hospitalizationTimepoint: Up to 12 weeks;Rescue medication use averaged over 12 weeks of treatment.Timepoint: Up to 12 weeks;Compliance with the study medication. Timepoint: Visit 2 (Week 4), Visit 3 (Week 8) & End of study (Visit 4 / Week 12);Assessment of patient satisfaction with the treatment. Timepoint: At End of study (Visit 4 / Week 12);Assessment of physician satisfaction with the treatmentTimepoint: At End of study (Visit 4 / Week 12) | — |
Countries
India
Contacts
Public ContactDr Hardik Pathak
Zydus Healthcare Limited
Outcome results
None listed