Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Vilanterol, Glycopyrronium and Fluticasone furoate capsule: Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation 25 mcg, 50 mcg and 100 mcg (Dry Powder Inhalation- DPI)
to be
Sponsors
Zydus Healthcare Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender between 40-65 years of age (both inclusive) 2. Patients who are current or ex-smokers 3. Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit: a. Post-bronchodilator FEV1/FVC ratio less than 0.7; b. Post-bronchodilator FEV1, more than or equal to 30% to less than 80% predicted 4. Clinically stable COPD (patient shall be taking at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) within 4 weeks prior to the screening visit and during the screening period 5. COPD Assessment Test (CAT) score more than or equal to 10 at screening 6. Patients willing to provide written informed consent and comply with the protocol requirements 7. Patients literate enough to fill the diary card
Exclusion criteria
Exclusion criteria: 1. Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc. 2. Patients with known hypersensitivity to vilanterol, glycopyrronium, fluticasone, salbutamol, other beta-2 agonists or other anti-muscarinic agents 3. Patients diagnosed with COVID-19 within 3 months prior to screening 4. Patients with known alpha1 antitrypsin deficiency 5. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period 6. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period 7. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period 8. Patients who required long-term oxygen therapy (more than equal to 12 hours/day) within 4 weeks prior to the screening or during the screening period 9. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention 10. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 11. Patients with hepatic dysfunction (serum transaminases more than equal to 3 times of Upper Normal Limit) or renal dysfunction (serum creatinine more than equal to 2.5 mg/dl) at screening 12. Patients who have used prohibited medications 13. Patients with continuing history of alcohol and/or drug abuse 14. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 15. Participation in another clinical trial in the past 3 months 16. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1 at the end of the studyTimepoint: At 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Change from baseline in trough FEV1 at week 4 Change from baseline in trough FVC at week 4 & at the end of the study Change from baseline in post-bronchodilator FEV1 & FVC at week 4 & at the end of the study Change from baseline in CAT score at week 4, week 8 & at the end of the study Responder rate at week 4 & at the end of the study COPD exacerbations reported during the study Rescue medication use during the treatment period Safety: Adverse events reported during the study Serious adverse events reported during the studyTimepoint: At week 4, week 8 & at the end of the study | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Zydus Healthcare Ltd.
Outcome results
None listed