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
- Other and unspecified asthma,
- Registration Number
- CTRI/2023/10/058653
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
An Open Label Single Arm, Multicentric, Prospective, Post Marketing Study to Evaluate the Safety And Effectiveness of Fluticasone Furoate/ Vilanterol (FF/VI) DPI in the Management of Asthma Patients (Promise OD)
Asthma is a chronic inflammatory disorder of the airways associated with hyper responsiveness of airways. Global Burden of Disease (GBD, 1990–2019) estimated the total burden of asthma in India as 34.3 million, accounting for 13.09% of the global burden. There has been a wide range of medication non-adherence rates among patients with asthma, ranging from 30 to 70 percent.
Patients with asthma have inadequately controlled disease despite treatment with an inhaled corticosteroid (ICS) and a long-acting Beta 2 agonist (LABA). The addition of a long-acting muscarinic antagonist (LAMA) may provide further benefit, but has traditionally required the use of two separate inhalers. The current Global Initiative for Asthma (GINA 2022) strategy document recommends using ICS/Formoterol combination both as a daily controller and as a rescue medication (MART) as a preferred strategy across. Recommendations by GINA represent a global strategy document but not guideline; therefore, there is a need of treatment strategy based on professional judgment, population characteristics and local healthcare systems.
This is an Open Label Single Arm, Multicentric, Prospective, Post Marketing Study to Evaluate the Safety And Effectiveness of Fluticasone Furoate/ Vilanterol (FF/VI) DPI in the Management of Asthma Patients. 178 subjects will be enrolled in this study across 6 centers in India. The treatment duration for each subject will be 12 Weeks. Number of patients with drug related and non-related TEAEs, Number of patients with serious TEAEs up to 12 weeks will be primarily evaluated. Mean change in FEV1 and ACQ-5 score, proportion of patient requiring hospitalization, Rescue medication use, compliance with the study medication, assessment of patient’s satisfaction and physician’s satisfaction with the treatment upto 12 weeks will be evaluated as secondary endpoints.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 178
- 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.
- Patient/parent/legal guardian willing to give a written informed consent/parental consent/assent form.
- Able to/Willing to strictly adhere to the investigator’s prescription.
- 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 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.
- 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.
- 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 To evaluate the safety of patients with asthma in India treated with FF/VI in terms of - Up to 12 Weeks • Number of patients with any drug related treatment emergent adverse events Up to 12 Weeks (TEAEs). [Time frame: up to Week 12] Up to 12 Weeks • Number of patients with TEAEs [Time Frame: up to Week 12] Up to 12 Weeks • Number of patients with serious TEAEs (STEAEs) [Time Frame: up to Week 12] Up to 12 Weeks
- Secondary Outcome Measures
Name Time Method Mean change in Trough FEV1 from baseline. Mean change in ACQ-5 score from baseline.
Trial Locations
- Locations (6)
Government Hospital for Chest and Communicable Diseases (GHCCD) affiliated with KGH
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
St Anns General and Cancer Hospital
🇮🇳Warangal, TELANGANA, India
Gillurkar Multispeciality Hospital
🇮🇳Nagpur, MAHARASHTRA, India
King Georges Medical Hospital
🇮🇳Lucknow, UTTAR PRADESH, India
MV Hospital and research centre
🇮🇳Lucknow, UTTAR PRADESH, India
Utkal Hospital
🇮🇳Khordha, ORISSA, India
Government Hospital for Chest and Communicable Diseases (GHCCD) affiliated with KGH🇮🇳Visakhapatnam, ANDHRA PRADESH, IndiaDr Raghumanda Sunil KumarPrincipal investigator9849126543chestdrsunil@gmail.com