Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: VILOR FG 100 DPI: FDC of Glycopyrronium 50 mcg, Fluticasone furoate 100 mcg and Vilanterol 25 mcg dry
powder (DPI) for inhalation for 12 weeks
Control Intervention1: Not Applicable: N
Sponsors
Glenmark Pharmaceuticals Ltd
Clinical Research Network India
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients aged more than or equal to 40 years with diagnosis of COPD as defined by the GOLD Guidelines 2024 Global Initiative for Chronic Obstructive Lung Disease GOLD 2024 2 Post bronchodilator FEV1/FVC less than 0.70 and post-bronchodilator FEV1 more than or equal to 30 percent predicted and less than 80 percent predicted 3 Symptomatic patients receiving ongoing maintenance therapy ICS/LABA or LAMA or LABA/LAMA 4 Patients with exacerbation history in past 1 year. 5 Ability to use DPI independently and correctly in view of the investigator 6 Patient is willing to sign a written informed consent form and agree to follow up on a regular basis as specified in the protocol
Exclusion criteria
Exclusion criteria: 1 Documented current diagnosis of asthma 2 Ongoing treatment with Triple therapy (i.e. ICS/LABA/LAMA) 3 Subjects with any life threatening condition or requiring hospitalization for management of current condition 4 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 5 Subjects with history of hypersensitivity to the active substance or to any of its excipients of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of VILOR FG 100 DPI in treatment of moderate to severe COPD in Indian population. Co-Primary: To evaluate the efficacy of VILOR FG 100 DPI, in terms of lung function improvement in treatment of moderate to severe COPD in Indian population.Timepoint: 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of VILOR FG 100 DPI, in terms of patient satisfaction and outcome in treatment of moderate to severe COPD in Indian population.Timepoint: 12 Weeks | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed