A prospective, open label, single-arm, multicentre, active post-marketing surveillance study to assess safety and effectiveness of Vilanterol 25 mcg and Fluticasone Furoate 200 mcg powder for inhalation in patients with asthma.
Overview
- Phase
- Post Marketing Surveillance
- Status
- Completed
- Sponsor
- Zydus Healthcare Limited
- Enrollment
- 190
- Locations
- 8
- Primary Endpoint
- 1. Number of patients with any drug related treatment emergent adverse events (TEAEs) in time-frame up to 12 weeks
Overview
Brief Summary
This is an prospective, open label, single-arm, multicentre, active post-marketing surveillance study to assess safety and effectiveness of Vilanterol 25 mcg and Fluticasone Furoate 200 mcg powder for inhalation in patients with asthma.
The patients with documented diagnosis of asthma will be directly enrolled (visit 1) in this active PMS study. The eligible patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 2), week 8 (visit 3) and week 12 (visit 4). All the enrolled patients will be instructed to take the study medication for a treatment period of 12 weeks.
All patients will be advised to take 1 capsule to be inhaled daily for 12 Weeks. It should be taken through Respihaler device. It should be administered at the same time of the day, each day. If a dose is missed, the next dose should be taken at the usual time the next day. After inhalation, patients should rinse their mouth with water without swallowing.
Use of Salbutamol MDI (100 mcg/puff) would be permitted only as a rescue medication. The patients will be instructed to take 1-2 puffs of salbutamol MDI in the event of acute breathlessness, with a maximum of 8 puffs in a day.
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 12.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex between 12 to 75 years of age (both inclusive) with a documented diagnosis of asthma
- •Pre-bronchodilator FEV1 of 40 percentage to 80 percentage of the predicted normal value at visit 1
- •Symptomatic patients receiving ongoing treatment with either ICS-SABA or ICS LABA or SMART
- •ACQ-5 score more than or equal to 1.5 at baseline.
- •Patient or parent or legal guardian willing to give a written informed consent or parental consent or assent form.
- •Able to or Willing to strictly adhere to the investigators prescription.
Exclusion Criteria
- •History of current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition).
- •Smoking history of more than 10 pack-years
- •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.
- •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.
- •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.
Outcomes
Primary Outcomes
1. Number of patients with any drug related treatment emergent adverse events (TEAEs) in time-frame up to 12 weeks
Time Frame: Up to 12 weeks
2. Number of patients with all TEAEs in time-frame up to 12 weeks
Time Frame: Up to 12 weeks
3. Number of patients with serious TEAEs in time-frame up to 12 weeks
Time Frame: Up to 12 weeks
Secondary Outcomes
- Assessment of patient satisfaction with the treatment.
- Mean change in trough FEV1 from baseline to 12 weeks(Baseline (Visit 1 / Day 0))
- Mean change in ACQ-5 score from baseline to 4 week, 8 week and 12 weeks(Baseline (Visit 1 / Day 0),)
- Mean change in trough FVC from baseline to 12 weeks(At baseline (Visit 1 / Day 0))
- Proportion of patients requiring hospitalization(Up to 12 weeks)
- Rescue medication use averaged over 12 weeks of treatment.(Up to 12 weeks)
- Compliance with the study medication.
- Assessment of physician satisfaction with the treatment(At End of study (Visit 4 / Week 12))
Investigators
Dr Deven V Parmar
Zydus Healthcare Limited