Health Condition 1: J44- Other chronic obstructive pulmonary disease
Conditions
Interventions
Intervention1: Neb GFB (Nebulized fixed-dose Glycopyrronium 25 g +
Formoterol 20 g + Budesonide 500 g): Name of Product: Neb GFB (Nebulized fixed-dose Glycopyrronium 25 g + Formoterol 20 g +
Bu
Sponsors
Glenmark Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged more than or equal to 40 years Confirmed COPD diagnosis with post bronchodilator FEV1 by FVC less than 0.70 Symptomatic patients receiving ongoing treatment with SITT DPI or pMDI with mMRC score more than or equal to 2 Patients with post bronchodilator FEV1 between 30 to 80 percent predicted Able to provide informed consent and comply with study procedures Able and willing to use a nebulizer device Able and willing to strictly adhere to investigators prescription
Exclusion criteria
Exclusion criteria: Severe COPD exacerbation requiring hospitalization, emergency room visit, or systemic corticosteroids in the last 4 weeks before baseline Primary diagnosis of asthma, interstitial lung disease, pulmonary fibrosis, or bronchiectasis 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. Subjects with history of hypersensitivity to the active substance or to any of its excipients of study drug. Any condition that, in investigator judgment, precludes safe participation or reliable data capture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of Neb GFB in symptomatic COPD patients switched from SITT DPI/pMDITimepoint: Mean change in mMRC dyspnea score from baseline and at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Neb GFB in symptomatic COPD patients switched from SITT DPI/pMDITimepoint: Secondary endpoints (Effectiveness): 1) Mean change from baseline in 2 hrs post dose FEV1 on day 1 2) Mean change in Trough FEV1 and trough FVC from baseline and at weeks 1, 2, 4, 8, 12 3) Mean change in mMRC dyspnea score from baseline and at weeks 1, 2, 4, 8. 4) Proportion of patients achieving Clinically Meaningful Dyspnea Improvement ( more than or equal to 1 point reduction in mMRC score) from baseline to weeks 2, 4, 8, 12 (mMRC responders) 5) Proportion of patients experiencing exacerbations during the study period. 6) Proportion of patients requiring hospitalization during the study period 7) Rescue medication use averaged over week 12 of treatment SABA (pMDI salbutamol) will be allowed to be used as a rescue medication throughout the study 8) Proportion of patients requiring oral steroids and antibiotics [Time frame: 12 weeks] 9) Compliance with the study medication in terms of treatment adherence and persistence following the switch [Time frame: At week 12] 10) Assessment of patient s satisfaction with the treatment [Time frame: 12 weeks] 11) Assessment of physician s satisfaction with the treatment [Time frame: 12 weeks] Secondary Endpoint (Safety): 1) Number of patients with any drug related treatment emergent adverse events (TEAEs). [Time frame: up to 12 weeks] 2) Number of patients with TEAEs [Time Frame: up to 12 weeks] 3) Number of patients with serious TEAEs (STEAEs) [Time Frame: up to 12 weeks] Exploratory Endpoints: 1) Proportion of patients achieving more than 100 ml improvement in FEV1 at week 1,2,4,8,12 | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
GLENMARK PHARMACEUTICALS LIMITED
Outcome results
None listed