Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Vilanterol, Glycopyrronium and
Fluticasone furoate Inhalation 12.5 mcg, 25 mcg and 50 mcg
: Patients will dispensed 2 MDIs each
one for the morning dose and another for the evening dose during visit 2 and visit 4. The MDI for morning dose will contain the test drug, Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation
one for the morning dose
and another for the evening dose during visit 2 and visit 4. Both the MDIs will contain
the reference drug, Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation 9 m
Sponsors
Zydus Healthcare Limited
Clinical Research Network India CRO
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender between 40-65 years of age (both inclusive) 2. Patients who are current/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 b. Post-bronchodilator FEV1, = 30% to 4. COPD Assessment Test (CATTM) score = 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4 weeks at the time of screening 5. Patients willing to provide written informed consent and comply with the protocol requirements 6. 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 formoterol, vilanterol, glycopyrronium, fluticasone, budesonide, 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 a1 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 (=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 = 3 x Upper Normal Limit) or renal dysfunction (serum creatinine = 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 study in the two groups Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1 at week 4 in the two groups Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Zydus Healthcare Limited
Outcome results
None listed