A POST MARKETING STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF FLUTICASONE FUROATE/ VILANTEROL (FF/VI) DPI IN THE MANAGEMENT OF ASTHMA PATIENTS (PROMISE OD)
- Conditions
- Health Condition 1: J459- Other and unspecified asthma
- Registration Number
- CTRI/2023/10/058653
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method