Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Fluticasone Furoate 100 mcg +Glycopyrronium Bromide Ph. Eur. eq. to Glycopyrronium 50 mcg + Vilanterol Trifenatate eq. to Vilanterol 25 mcg: 100 mcg + 50 mcg + 25 mcg,
Once Daily,
Dry P
Sponsors
Dr Lokesh Kumar General Manager
Raptim Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18 years and above. 2. Diagnosed with moderate to severe COPD as per the Global Initiative for Obstructive Lung Disease (GOLD) 2023 guidelines classification. 3. COPD Assessment Test (CAT) score = 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4-6 weeks at the time of screening. 4. Willing to take the medications as directed. 5. Willing to comply with the protocol requirements. 6. Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures. 7. Post-menopausal female patients, or female of child bearing age must agree to use highly effective contraceptive measures with her partner during the study and for 90 days following their last dose.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Fluticasone, Glycopyrronium, Vilanterol, other beta-2 agonists, other anti-muscarinic agents, other corticosteroids or excipients of formulation. 2. Known a1-antitrypsin deficiency. 3. Known history of HIV or HBV or HCV infection. 4. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period. 5. Hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period. 6. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period. 7. Known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention. 8. Clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy. 9. Known history of hepatic dysfunction. 10. With continuing history of alcohol and/or drug abuse. 11. Not willing to give written informed consent. 12. Any other condition/ uncontrolled co-morbid conditions that, in the opinion of the investigator, does not justify the inclusion of the patient in the study. 13. Pregnant women. 14. Lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients with Adverse Events (AEs) Incidence rate of AEs (Serious/non-serious, Expected/Non- expected, Related/ Non-related) Safety of patient will be monitored throughout the study Timepoint: Entire duration of Study and at Week 6 and a Week 12 (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in COPD Assessment Test (CAT) score at week 12 from baseline. Proportion of patients with improvement in modified Medical Research Council (mMRC) score at end of week 12. CAT comprises 8 questions; each is presented as a 6-point (0-5) differential scale, providing a total score out of 40. Scores of 0-10, 11-20, 21-30, 31-40 represent mild, moderate, severe or very severe clinical impact, respectively. The mMRC dyspnea score is a 5-point (0-4) scale based on the severity of dyspnea experienced by patient as shown below: Timepoint: At Week 6 & a Week 12 (EOS) | — |
Countries
India
Contacts
Public ContactDr Siddhartha Patil
Raptim Research Pvt. Ltd.
Outcome results
None listed